10 Regulatory Standards jobs in Australia

Title:
Quality Assurance Technician
Belong. Connect. Grow. with KBR!
KBR's National Security Solutions team provides high-end engineering and advanced technology solutions to our customers in the intelligence and national security communities. In this position, your work will have a profound impact on the country's most critical role - protecting our national security.
Why Join Us?
+ Innovative Projects: KBR's work is at the forefront of engineering, logistics, operations, science, program management, mission IT and cybersecurity solutions.
+ Collaborative Environment: Be part of a dynamic team that thrives on collaboration and innovation, fostering a supportive and intellectually stimulating workplace.
+ Impactful Work: Your contributions will be pivotal in designing and optimizing defense systems that ensure national security and shape the future of space defense.
This is a contingent position based upon contract award
Who We AreKBR Government Solutions delivers full life cycle professional and technical solutions that improve operational readiness and drive innovation. Our solutions help ensure mission success on land, air, sea, space and cyberspace for the Department of Defense, Intelligence Community, NASA and other federal agencies. KBR's areas of expertise include engineering, logistics, operations, science, program management, mission IT and cybersecurity. KBR strives to create a safer, more secure and sustainable world by bringing together the best and brightest to deliver technologies and solutions that help our customers accomplish their most critical missions and objectives.
The Mission AheadThis role is with KBR's Government Solutions U.S. division. At KBR Government Solutions, we don't just envision a world that's safer, more secure, and sustainable - we create it. Our legacy of delivering advanced full life cycle professional and technical solutions is matched only by our commitment to operational readiness and innovation. As stewards of critical missions for the Department of Defense, Intelligence Community, NASA, and other key federal entities, we excel in engineering, logistics, operations, science, program management, mission IT, and cybersecurity. United in our quest for excellence, KBR stands at the vanguard, ready to transform possibilities into impactful realities for a better tomorrow.
Who You AreYou're a detail-oriented and analytical Quality Assurance Technician with a strong ability to ensure products, services, and processes meet established standards of quality and reliability. With expertise in inspections, testing, and documentation, you excel at identifying and resolving issues to maintain compliance with regulatory and organizational requirements. Your knowledge of quality control procedures, attention to detail, and problem-solving skills ensure operational excellence.
At KBR, you bring a commitment to precision, thoroughness, and continuous improvement to every task. Known for your ability to work collaboratively and communicate effectively, you support teams in achieving quality benchmarks and driving mission success. Your dedication to upholding the highest standards aligns with KBR's mission of delivering innovative and reliable solutions for critical operations.
What You'll DoIn the role of Quality Assurance Technician, your duties will include:
+ Provides support in quality assurance (QA) tasks, collaborating with the QA team.
+ Assists in organizing and conducting quality training programs.
+ Participates in quality audits to assess compliance with established standards and identify areas for improvement.
+ Uses basic quality tools and principles to contribute to problem-solving efforts and assess the effectiveness of solutions.
+ Creates inspection reports to document work area conditions and ensure compliance with quality requirements.
+ Recommends corrective actions based on inspection findings to address deviations from standards.
+ Validates and verifies compliance with contractual quality standards.
+ Ensures alignment between the quality management function and performance needs.
+ Inspects materials received from vendors to ensure compliance with contractual requirements.
+ Documents nonconformities and assists in follow-up audits on corrective actions.
+ Supports inspections to ensure compliance with documented procedures/contract requirements.
+ Develops quality inspection checklists to facilitate inspection processes and ensure thoroughness.
Qualifications:
+ Must be a US or AUS Citizen
+ Must possess a US TS/SCI with Polygraph or AUS PV Clearance.
+ Must have a minimum of one year of quality experience.
+ Thorough knowledge of methodologies of quality assurance and standards.
+ Excellent numerical skills and understanding of data analysis/statistical methods.
+ Attention to Detail: Precision and attention to detail to ensure high-quality service delivery and compliance with safety standards.
+ Adaptability: Flexibility to adapt to changing conditions, technologies, and requirements.
+ Decision-Making Ability: Strong decision-making skills to resolve issues quickly and effectively under pressure
Desired Qualifications:
+ ASQ Certification or Australian Equivalent
#SF
Belong, Connect and Grow at KBRAt KBR, we are passionate about our people and our Zero Harm culture. These inform all that we do and are at the heart of our commitment to, and ongoing journey toward being a People First company. That commitment is central to our team of team's philosophy and fosters an environment where everyone can Belong, Connect and Grow. We Deliver - Together.
KBR is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, disability, sex, sexual orientation, gender identity or expression, age, national origin, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law.

Position Title: Quality Assurance Manager
Company: M&A Cabinets br>Location: Truganina, VIC 3029
Salary: $76,000 – $85,000 AUD per annum < r>ANZSCO Code: 139916
About the Company
M&A Cabinets is a leading manufacturer and installer of high-quality custom cabinetry and joinery, proudly serving commercial and residential clients across Victoria. Known for precision craftsmanship and a commitment to excellence, we specialise in kitchens, wardrobes, vanities, and bespoke cabinet solutions tailored to each client's unique needs. With a growing customer base and a reputation built on trust, quality, and innovation, we are now seeking a dedicated Quality Assurance Manager to join our team and uphold the standards that define our brand.
About the Role
As the Quality Assurance Manager, you will play a key role in maintaining and enhancing the quality of our cabinet manufacturing processes, ensuring all products meet strict internal standards, client expectations, and regulatory requirements. You’ll lead quality control systems, ensure compliance with safety standards, and foster a culture of continuous improvement across our production operations. < r>Key Responsibilities
• Develop, implement, and oversee robust quality assurance frameworks across all stages of cabinetry design, production, and installation. < r>• stablish and monitor quality benchmarks to maintain consistency in product measurements, finishes, materials, and structural integrity. < r>• C nduct regular inspections and audits of raw materials, in-process components, and final products to ensure compliance with internal and Australian quality standards. < r>• L ad root cause analysis of product non-conformities and implement effective corrective and preventive actions. < r>• W rk closely with production teams to identify process improvements, enhance efficiency, and reduce rework or wastage. < r>• E sure workplace health and safety compliance in accordance with relevant legislation and industry guidelines. < r>• T ain and guide staff on quality control procedures, safe handling of materials, and best practices in cabinet assembly and installation. < r>• L aise with suppliers to ensure the consistency and reliability of materials supplied, addressing quality concerns as needed. < r>• M intain comprehensive documentation of quality control activities, inspection results, and compliance records. < r>• A alyze client feedback, warranty issues, and customer service trends to enhance product quality and satisfaction. < r>• P epare and present quality performance reports to senior management and support business goals through strategic quality initiatives. < r>• S ay updated on regulatory requirements, materials standards, and industry innovations to ensure continued excellence. < r>Skills & Qualifications
• B chelor’s degree in Engineering, Quality Management, Manufacturing, or a related discipline.
• S rong knowledge of QA systems, audit processes, and regulatory standards (e.g., ISO 9001, OH&S). < r>• E cellent communication, problem-solving, and leadership skills. < r>• H gh attention to detail, with the ability to work in a fast-paced and hands-on production environment. < r>• P oficient in using QA tools, software, and reporting systems. < r>Why Join M&A Cabinets?
• B part of a reputable and rapidly growing business in the manufacturing sector. < r>• W rk with a passionate team committed to excellence in design, construction, and installation. < r>• E joy a supportive and collaborative work environment with opportunities for career growth. < r>• C ntribute to delivering high-end products that shape interior spaces across Victoria.

Title:
Assistant Quality Assurance Manager
At KBR - We do things that matter.
We deliver science, technology and engineering solutions to governments and companies around the world. KBR employs approximately 38,000 people worldwide with customers in more than 80 countries and operations in over 29 countries.
KBR is proud to work with its customers across the globe to provide technology, value-added services, and long-term operations and maintenance services to ensure consistent delivery with predictable results. At KBR, We Deliver.
Think.KBR.com
KBR in Australia
With over 65 years working on some of Australia's largest and most complex projects, KBR has unmatched experience supporting the nation's critical infrastructure, energy transition and national security priorities. KBR has around 2,000 employees throughout Australia, who are focused on delivering innovative technology and engineering solutions for a safer, more secure and sustainable future.
Learn more about KBR in Australia
Belong, Connect and Grow at KBR
At KBR, we are passionate about our people and our Zero Harm culture. These inform all that we do and are at the heart of our commitment to, and ongoing journey toward being a People First company. That commitment is central to our team of team's philosophy and fosters an environment where everyone can Belong, Connect and Grow. We Deliver - Together.
The Opportunity:
Our client, a leading Managed Services Provider (MSP) supporting Defence capability, is seeking an Assistant Quality Manager with strong systems engineering experience to join a high-performing team on a Defence program in Brisbane. This position plays a key role in ensuring engineering processes, quality frameworks, and compliance obligations are met in line with Defence standards.
Reporting to the Quality Manager, you will support the assurance of engineering and technical deliverables, contributing to risk management, systems safety, and quality audits throughout the systems lifecycle. This role supports supply chain optimisation by conducting network studies, coordinating with stakeholders, and ensuring the timely delivery of goods and services. Through independent problem-solving and collaboration, the specialist contributes to the effective execution of logistics operations and supports continuous improvement initiatives across the organisation.
Responsibilities:
+ Support the development, implementation and continuous improvement of the Quality Management System (QMS) in accordance with ISO 9001 and AS9100 standards.
+ Ensure engineering processes align with Defence and MSP quality standards and customer requirements.
+ Conduct internal quality audits and support external audits (e.g., by CASG, primes, or other stakeholders).
+ Assist in systems safety and assurance tasks aligned with the One Defence Capability System (ODCS) and other acquisition frameworks.
+ Engage with multi-disciplinary engineering teams to embed quality into the design, development, and sustainment processes.
+ Participate in root cause analysis, risk reviews, and engineering change control procedures.
+ Maintain quality records and contribute to lessons-learned repositories.
+ Liaise with systems engineers and project managers to ensure compliance and traceability throughout the V&V lifecycle.
As the ideal candidate you will bring:
+ Engineering degree in Systems, Aerospace, Mechanical, Electrical, or related field.
+ Experience in Defence engineering environments and understanding of Defence capability lifecycle (ODCS).
+ Sound knowledge of quality management systems, assurance frameworks, and ISO/AS standards.
+ Strong background or exposure to Systems Engineering, particularly in requirements traceability, verification and validation (V&V), and interface management.
+ Exposure to systems safety and risk management principles (e.g. MIL-STD-882, T&E, hazard logs).
+ Proficiency in document control and configuration management tools (e.g. DOORS, Windchill, Teamcenter).
+ Strong communication and stakeholder engagement skills.
All candidates will be required to hold and maintain an active NV1 Defence Security Clearance. Only candidates holding a NV1 Clearance or above should apply.
What we will offer you:
· A workplace culture certified as a Great Place To Work
· Flexible working
· Competitive salary (including annual reviews)
· Paid parental leave
· Income protection
· Corporate rewards
· Salary packaging/Novated leasing
· Employee stock purchase plans
· Flu shots, skin checks and discounted private health insurance
· Career development: Online learning, mentorship and career pathways
If you're ready to shape tomorrow, let's get started. Apply Now!
As a Major Service Provider of the Australian Defence Force, an AGSVA security clearance will be required and compliance to International Traffic in Arms Regulations (ITAR). As such, our hiring decisions are based on the key requirements of each role and candidates are selected based on their unique strengths and experiences.

Director, Quality Assurance APAC
Australia
Japan
Sydney, New South Wales, Australia
Singapore
+ **Market leading developer & manufacturer of medical devices for Women's Health**
+ **Newly created role with an innovative and growing organisation**
+ **Australia or Singapore based with role scope across APAC**
Are you looking for a place where the work you do is directly connected to positively impacting lives around the world? Are you searching for an opportunity that allows you to focus on your strengths each day? Let us start a conversation.
Hologic is an innovative medical technology company primarily focused on improving Women's Health and well-being through early detection and treatment. We develop, manufacture and supply life-changing Diagnostics, GYN Surgical and Breast & Skeletal Solutions that are founded on science and driven by technology; allowing healthcare professionals to diagnose and proactively treat patients with growing certainty, precision, and greater peace of mind.
Join us as a Senior Manager, Quality Assurance where you will represent a leading brand and be responsible for managing the APAC commercial quality organization. You will ensure high quality standards and compliance with regulatory requirements and internal policies. In this role you will be responsible for assessing current systems and practices, identifying gaps and developing comprehensive solutions to harmonize and optimize quality processes across the APAC region. You will be based in either Australia or Singapore and lead a team of three (based in Australia, Singapore and Japan), supporting them with managing QA requirements for their region.
To be successful in this role, you are an authentic leader and team player who is passionate about coaching, developing and mentoring your team members. You have a Bachelor's degree in a scientific discipline and at least 8 years previous experience in quality with at least 3 years successfully leading a QA team across the APAC region. It will be essential that you have advanced knowledge of QSRs, ISO 13485, ISO 14971, MDSAP, and IVDR. Impeccable communication and presentation skills is a must as you will need to communicate and influence a variety of internal stakeholders
To be the best, we want the best.
In return, you will be joining a team that is talented, high achieving and collaborative. A team that is driven by the impact we have on our global community. We are proud of our positive team environment where work life balance, engagement and the wellbeing of our employees is a priority. We are offering a competitive salary that is based on experience as well as participation in an annual bonus structure. We offer a flexible working environment, where most of our employees work hybrid between home and our office.
As part of this role, you will be required to travel across APAC.
We make hiring decisions based on your experience, skills, and passion. Please note that interviews may be conducted virtually. When you apply, please tell us the pronouns you use and any reasonable adjustments you may need during the interview process
_If you are driven by the pursuit of a healthier & more enriched life for yourself, family & those around you, please apply._
#LI-TL1

Director, Quality Assurance APAC
Australia
Japan
Sydney, New South Wales, Australia
Singapore
+ **Market leading developer & manufacturer of medical devices for Women's Health**
+ **Newly created role with an innovative and growing organisation**
+ **Australia or Singapore based with role scope across APAC**
Are you looking for a place where the work you do is directly connected to positively impacting lives around the world? Are you searching for an opportunity that allows you to focus on your strengths each day? Let us start a conversation.
Hologic is an innovative medical technology company primarily focused on improving Women's Health and well-being through early detection and treatment. We develop, manufacture and supply life-changing Diagnostics, GYN Surgical and Breast & Skeletal Solutions that are founded on science and driven by technology; allowing healthcare professionals to diagnose and proactively treat patients with growing certainty, precision, and greater peace of mind.
Join us as a Senior Manager, Quality Assurance where you will represent a leading brand and be responsible for managing the APAC commercial quality organization. You will ensure high quality standards and compliance with regulatory requirements and internal policies. In this role you will be responsible for assessing current systems and practices, identifying gaps and developing comprehensive solutions to harmonize and optimize quality processes across the APAC region. You will be based in either Australia or Singapore and lead a team of three (based in Australia, Singapore and Japan), supporting them with managing QA requirements for their region.
To be successful in this role, you are an authentic leader and team player who is passionate about coaching, developing and mentoring your team members. You have a Bachelor's degree in a scientific discipline and at least 8 years previous experience in quality with at least 3 years successfully leading a QA team across the APAC region. It will be essential that you have advanced knowledge of QSRs, ISO 13485, ISO 14971, MDSAP, and IVDR. Impeccable communication and presentation skills is a must as you will need to communicate and influence a variety of internal stakeholders
To be the best, we want the best.
In return, you will be joining a team that is talented, high achieving and collaborative. A team that is driven by the impact we have on our global community. We are proud of our positive team environment where work life balance, engagement and the wellbeing of our employees is a priority. We are offering a competitive salary that is based on experience as well as participation in an annual bonus structure. We offer a flexible working environment, where most of our employees work hybrid between home and our office.
As part of this role, you will be required to travel across APAC.
We make hiring decisions based on your experience, skills, and passion. Please note that interviews may be conducted virtually. When you apply, please tell us the pronouns you use and any reasonable adjustments you may need during the interview process
_If you are driven by the pursuit of a healthier & more enriched life for yourself, family & those around you, please apply._
#LI-TL1

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
At Gilead, we're committed to creating a healthier world for everyone - no matter the challenges ahead of us. For more than 30 years, we've pursued the impossible, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Through bold and transformative science, we're driving innovation that has the potential to become the next generation of life-changing medicines. Our ambition is evident in our mission. Because the impossible is not impossible. It's what's next.
The Position:
We are seeking a highly experienced and motivated individual to join us as Associate Director or Senior Manager, Product and Distribution Quality in ANZ. You will work with Quality, Commercial, Regulatory, Supply Chain, and Medical Affair in supporting our efforts in this exciting area of cancer immunotherapy. This individual will work cross functionally to lead a multi-market organization focused on implementing and ensuring the qualification and monitoring program for hospital apheresis centers and treatment sites that will provide treatment to patients with our commercial products, investigations related to product complaints, the cross-functional work for global labeling capabilities, the full set of capabilities associated to Responsible Person (RP) in ANZ and other APAC region as needed, and representing QA in ANZ regional Leadership teams as well as representing Kite with external partners and others.
Key Responsibilities will include:
+ Establish, execute and manage the new and established apheresis centers and treatment centers sites (ACTS) qualification process that will use risk-based tools for qualification, training and monitoring.
+ With Global Site Qualification will determine strategy for maturing the ongoing program, sustainability and compliance to regulatory changes.
+ Collaborate with cross-functional departments to ensure timely implementation of quality processes.
+ Provide leadership and direction in the industry in the area of site qualification process and management.
+ Assess and approve any changes to the courier tracking and order intake systems to assure the validated state of the systems is maintained.
+ Lead Quality's collaboration efforts with Commercial in the start-up and routine management of the ATCS relationship and Supply Chain to ensure compliance across the Kite product Journey and best customer experience
+ Implement, assess and report on metrics monitoring per schedule and provide updates to approved ATC list.
+ Assure business systems are developed, supported and maintained validated state for patient traceability.
+ Act as Quality contact, or delegate, for ATCS issues and discrepancies, and lead/manage the investigations to resolve the issues.
+ Interacts with the Kite T cell Facilities as needed for product release, issue resolving or other as applicable
+ Support inspection readiness plans and interact with regulatory agencies during inspections on ATCS-related matters.
+ Work with Global Site Qualification, America, EME and APAC regional leads , as needed.
+ Collaborate with our Gilead affiliates in the routine management of the ACTS relationships and in other areas as needed
+ Serve as Gilead RP per the local guidelines (TGA, HSA etc.). Act as back-up for RP in other APAC region as needed. Verify lot distribution confirmation for Kite cell therapy product and related activities in compliance with local regulations and internal SOPs and supervise quality/regulatory aspects of distribution in Australia and Singapore.
+ Provide quality oversight and execute responsibilities designated for the Responsible Person in country that includes the following QMS: distribution (under GDP), product complaints, recall, returns, self-inspection.
+ Provide oversight of deviation investigations which occur during the manufacturing, packaging and shipment of products and provide QA oversight and approval of Change Control records impacting Cell Therapy products in Australia, Singapore and other APAC region.
+ Maintain local Quality System to comply with local regulation.
+ Quality lead for Material Review Board for Cell Therapy Finished Products for Australia and Singapore
+ Perform other duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
Knowledge, Experience and Skills Required:
+ Bachelor's degree in medical or biological sciences or related field; Master's or PhD degree preferred
+ Minimum of 7 years progressive experience in medical, pharmaceutical or biologics quality assurance' roles; preferred cell therapy.
+ Experience in areas such as Clinical Research, Medical Liaison, Cell Therapy and/or Apheresis and Cell Therapy Medical Centers preferred.
+ Experience auditing blood banks, plasma centers, apheresis centers, external suppliers and/or internal GMP systems.
+ Experience working in multi-national companies with management responsibilities of staff located in multiple regions/countries.
+ Proficiency in English is required
+ Strong working knowledge of and ability to apply GMP in conformance to ANZ.
+ Experience responding to regulatory agency audits.
+ Demonstrated ability to develop, coach, and mentor employees
+ Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
+ Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
+ Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
+ Ability to travel up to 40%, could include some weekend travel for arrival to/return from destinations
**Gilead Core Values**
Integrity (always doing the right thing)
Teamwork (collaborating in good faith)
Excellence (working at a high level of commitment and capability)
Accountability (taking personal responsibility)
Inclusion (encouraging diversity)
**Being Here Matters**
_At Gilead we are committed, hardworking and passionate about improving the lives of the patients who use our products. Our values - integrity, inclusion, teamwork, accountability and excellence - are evident in everything we do. We are a close-knit team where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development._
_We want all our employees to embrace and leverage each other's talents and diverse perspectives, foster a sense of belonging, achieve their full career potential and contribute to the team's success? This is demonstrated through our Silver Status in the Australian Workplace Equity Index?_
_As an equal opportunity employer, Gilead Sciences is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, colour, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws._
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Job Description:
McDonald's Australia is the largest quick service restaurant operation in the country. Fondly known as "Macca's", we have been a household name in Australia for over 50 years, we believe that our customers are the heart and soul of everything we do and make it our mission to make every moment count! As an employer of choice winner time and time again, working with us means taking pride and having fun along the way; while growing and developing your career in a dynamic and supportive environment.
Could you be our next Quality Assurance Coordinator?
The McDonald's Quality Assurance team have an exciting opportunity for someone to join them on a 12-month initial contract. As a Quality Assurance Coordinator, you will manage and communicate market and global quality systems and policies to internal and external stakeholders. You will support food safety and quality standards across Australia and New Zealand, working closely with suppliers and Quality Assurance Managers (QAMs) to develop and execute validation programs for food products and equipment. Do you have a passion for food safety and quality standards? Apply today!
What can you expect on a day-to-day basis?
+ Maintaining and updating the McDonald's Australia and New Zealand Quality Systems Manual
+ Conducting product and equipment validations in the test kitchen
+ Supporting Quality Assurance Managers in creating and maintaining product specifications
+ Coordinating restaurant trials for quality assurance projects
+ Leading the quality assurance information for the Implementation Deployment Team
+ Serving as the Digital Champion for McDonald's reporting systems
+ Analysing complaint data and audit results to identify trends
+ Managing the Class 1 Supplier Good Manufacturing Practice Unannounced Audit Schedule
+ Participating in annual audits for the test kitchen
+ Arranging importation of product samples for sensory analysis
+ Completing food safety checks for equipment and products
Your keys to success:
+ Degree/Diploma Qualified in Food Science/Technology or nearing completion
+ Committed to principles of food safety and driven to uphold these principles
+ A proven ability to work under pressure in both acute and planned environments
+ Self-motivated and proactive, takes the initiative to pre-empt opportunities
Relish in the Macca's difference when you join the Golden Arches:
+ Macca's Staff Discount & Retail Discounts. Enjoy discounted Macca's at any restaurant across Australia and access to hundreds of retail discounts.
+ Birthday & Volunteer Leave. Enjoy a day-off during your birthday month and 3 days annually to volunteer for a registered charity you are passionate about.
+ Modern Office with Sustainable Amenities. Newly revamped office located in Thornleigh featuring the latest technology and electric car chargers to support eco-friendly commuting.
+ Ongoing Professional Development. We are committed to developing our people by investing in leadership programs and free access to LinkedIn Learning.
+ Access To Our 24/7 Wellbeing Partner (Sonder) For You & Your Immediate Family. Using the Sonder app, access free and confidential safety, medical and mental health support via chat or phone with accredited professionals.
+ A Fun & Vibrant Culture. Immerse yourself in local and Macca's only events and experiences from day one of working with us.
At Macca's, our doors are open to everyone, and we will always do our best to ensure our restaurants and workplaces are inclusive spaces where everyone is welcomed and strength in diversity is valued. No matter who you are or where you're from, everyone at Macca's contributes their talents and skills to what makes us golden and what makes us Macca's. We strive to make every moment through the recruitment process a feel-good moment that is fair, equitable and accessible. If you have disability, illness, or injury, we know that it may be helpful for us to adjust our process. Our doors are open for a conversation to discuss adjustments and answer any questions or suggestions you may have about our recruitment process.
Requsition ID: 1791

**Key Areas of Responsibility:**
+ Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a technical and/or tactical nature
+ Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
+ Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
+ Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
+ Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
+ Evaluates proposed products for regulatory classification and jurisdiction
+ Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
+ Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
+ Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
+ Negotiates with regulatory authorities throughout the product lifecycle
+ Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
+ Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
+ Assists other departments in the development of SOPs to ensure regulatory compliance
+ Provides regulatory input and technical guidance on global regulatory requirements to product development teams
+ Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
+ Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
+ Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
+ Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
+ Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
+ Provides regulatory information and guidance for proposed product claims/labeling
+ Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
+ Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
+ Monitors the progress of the regulatory authority review process through appropriate communications with the agency
+ Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
+ Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
**Education / Work Experience:**
+ BS in Engineering, Science, or related degree; or MS in Regulatory Science
+ Typically a minimum of 4 years' experience
+ MS or RAC(s) preferred
**Knowledge / Competencies:**
+ Strong project management, writing, coordination, and execution of regulatory items
+ Emphasis on technical and scientific regulatory activities
+ Demonstrate knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance and distribution
+ Under general supervision, plans, conducts and supervises assignments
+ Reviews progress and evaluates results
+ Recommends changes in procedures
+ Operates with appreciable latitude for unreviewed action or decision
+ Reviews progress with management
+ May direct work of Specialist or Sr. Specialist
+ Seeks out diverse ideas, opinion, and insights and applies them in the workplace
+ Connects and relates well with people who think and act differently than oneself
+ Embraces scrutiny and accepts feedback as opportunity to learn and improve
+ Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
+ Navigates the dynamics, alliances, and competing requirements of the organization or business
+ Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting.
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The Regulatory Affairs (RA) Lead is responsible for regulatory strategy, submissions, license management, in-country testing, and audit support for regulated countries throughout the Asia/Asia Pacific (APAC) region. The Lead will serve as the subject matter expert on cross-functional projects to ensure key performance indicators are met. Provide guidance and training to associates to ensure skilled competencies of global Regulatory standards and requirements at Cepheid.
This position is part of Regulatory Affairs, Global Market Expansion and will be located in Australia. The role will report to the Senior Director, Regulatory Affairs.
In this role, you will have the opportunity to:
+ Serve in the following: preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to obtain product approvals.
+ Mentor and coach team on complex regulatory business initiatives.
+ Manage and translate strategy/plan into goals by building repeatable processes that help manage the team's sustained delivery on performance metrics.
The essential requirements of the job include:
+ Bachelor's degree with 8+ years of related work experience, OR Master's degree in field with 6+ years of related work experience, OR Doctoral degree in field with 3+ years of related work experience; AND at least 2 years supervising people.
+ Experience leading regulatory submissions and interactions with regulatory authorities (e.g. TGA) with an in-depth knowledge of global regulatory requirements, standards, and guidelines (including ISO 13485, and US FDA 21 CFR Part 820 Quality Systems regulations).
+ Strong written and communication skills; comfortable working in a dynamic multi-functional matrix organization.
Highly preferred requirements of the job include:
+ Experience in supporting Quality Assurance activities.
+ Technical experience within the in vitro diagnostic or medical device industries.
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
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At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
Operating Company: Cepheid