9 Regulatory Standards jobs in Australia

**About the Role**
Join Stryker South Pacific's 2025 Team of the Year! Join a team where quality is less about policing and more about partnering!
As a Quality Assurance Associate, you'll play a pivotal role in ensuring our operations meet the highest standards of compliance and quality. You'll manage key quality management processes in alignment with international standards, Stryker Corporate policies, and regulatory requirements in Australia and New Zealand. This role is highly collaborative, partnering across departments-Sales, Marketing, Regulatory, Service, and Operations-to drive a quality-first mindset and ensure patient safety and regulatory excellence.
We currently have both permanent and maximum-term contract opportunities are are looking for our next superstar team members!
**About You**
You're a detail-oriented problem-solver with great attention to detail, curiosity and a strong ability to develop meaningful relationships quickly. You thrive in complex, layered environments, enjoy collaborative work, and have a knack for translating complex concepts into practical business processes. You're proactive, analytical, and committed to continuous improvement.
**Key Responsibilities**
+ Own and manage QMS processes in accordance with ISO 13485 and regulatory standards;
+ Act as a key contact for quality issues across SSP and global teams;
+ Represent Stryker in internal and external audits;
+ Lead and support Change Control, Nonconformances (NCs), and Corrective and Preventive Actions (CAPAs);
+ Train and coach SSP personnel on quality processes and regulatory obligations;
+ Maintain and update standard operating procedures and ensure compliant record keeping and documentation; and
+ Drive process improvement initiatives and stay informed on regulatory changes and educate
**Must Have Experience**
+ Working knowledge of regulatory frameworks and legislation in Australia and New Zealand;
+ Experience analyzing and interpreting regulatory documentation;
+ Strong time management and planning skills;
+ Effective communication and stakeholder engagement abilities;
+ Ability to build relationships across diverse team; and
+ Receptive to feedback and committed to personal growth.
**Nice to Have Experience**
+ Prior experience in regulatory affairs or quality assurance;
+ Experience in a regulated industry, ideally medical devices;
+ Familiarity with Australian and international medical device regulations; and
+ Tertiary qualifications in science, engineering, or a related field
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 and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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.

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.

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.

**About the role:**
The Regulatory Affairs Lead is responsible for overseeing and driving key regulatory activities for Stryker South Pacific, ensuring compliance with relevant regulations and legislation.
This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point of escalation for complex regulatory matters. Additionally, the Regulatory Affairs Lead will coach and mentor team members, providing guidance to support their professional development.
**About you:**
You're an experienced regulatory professional with significant experience in a similar Regulatory Affairs role, ideally within the healthcare or medical devices industry (however this is not essential). You will bring a depth of knowledge and experience working within highly regulated industries, interacting with regulatory authorities and navigating complex regulatory environments. You also have strong leadership, strategic thinking, and technical expertise, with a proactive approach and a proven ability to coach teams and influence stakeholders.
**Key responsibilities**
+ **Strategic regulatory guidance:** provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and alignment with commercial goals;
+ **Risk management and compliance:** identify and mitigate regulatory risks, ensuring compliance with legislation, standards and corporate procedures while supporting post-market activities and change management;
+ **Process improvement and implementation:** Drive the implementation of new regulatory processes and contribute to continuous improvement initiatives that enhance compliance and operational efficiency;
+ **Stakeholder engagement and issue resolution:** act as a key escalation point for complex regulatory issues, offering strategic solutions and collaborating across teams to resolve challenges effectives; and
+ **Leadership and team development:** Mentor and coach team members, fostering growth and building technical competency to strengthen regulatory expertise across the team
**Must have experience/skills:**
+ A minimum of 8 years' experience within a Regulatory Affairs, Quality or similar field and demonstrable success in analysis and interpretation of regulatory documentation and technical writing;
+ Tertiary qualifications in a technical discipline (e.g. Science, Engineering, or related.);
+ Strong communication, negotiation and influencing skills - the ability to quickly build meaningful relationships with internal teams, external stakeholders and government departments; and
+ A self-driven, strategic thinker who can balance attention to detail and quality, with the ability to thrive in a fast-paced environment and high performance and growth organisation;
**Desired but not essential experience/skills:**
+ 5+ years of experience in Medical Device regulatory affairs, with a solid understanding of both Australian and international regulatory environments;
+ Strong knowledge of the medical device regulations in Australia and New Zealand. International regulatory knowledge also a plus! (e.g. FDA and EU MDR);
+ Experience with Prostheses List management; and
+ Team management experience.
**To join us, click apply now!**
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 and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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.

**About Abbott**
**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**
**Working at Abbott**
**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:**
**Career development with an international company where you can grow the career you dream of .**
**Amazing health and wellness benefits and perks.**
**A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.**
**A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**
**We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.**
**Overview**
**This role is responsible for the primary responsibility of regulatory activities in Australia and New Zealand. Including managing the regulatory submissions and product updates, approving advertising materials and being responsible for regulatory and legislation changes.**
**Responsibilities**
**Manage all aspects of product registration with regulatory authorities in Australia and New Zealand to ensure regulatory approvals are achieved in accordance with Company objectives. Monitor progress of applications through the regulatory system.**
**Be the main contact for TGA and Medsafe to facilitate evaluation and other regulatory processes.**
**Provide assessment on product and manufacturing changes in relation to regulatory actions.**
**Review and approving promotional material for compliance with relevant regulations and codes.**
**Be the SME of all Australian and New Zeal and Therapeutic Goods regulations and providing guidance and strategy for Affiliate and Global stakeholders**
**Provide training and guidance on Regulatory topics to stakeholders where applicable.**
**Maintain good working knowledge of relevant Federal and State Regulations and standard guidelines and procedures.**
**You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences. These events may take place on an evening and/or weekend.**
**Qualifications and Experience**
**Essential**
**Science Degree or equivalent**
**Minimum 7 years Regulatory experience within the medical devices or IVD industry.**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

**Job Description Summary**
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, pre-market submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.
This position is a 12 month maternity leave contract.
**Job Description**
**Roles and Responsibilities**
+ Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
+ Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
+ Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
+ Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
+ Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.
**Required Qualifications**
+ This role requires advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
**Desired Characteristics**
+ Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
**Additional Information**
**Relocation Assistance Provided:** No