6 Product Stewardship jobs in Australia

Title:
System Engineer - Risk Management
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 strategic and detail-oriented Systems Engineer: Risk Manager with a strong background in identifying, assessing, and mitigating risks within complex systems and projects. Your expertise in risk management, system architecture, and engineering principles allows you to develop robust strategies that minimize potential threats and ensure system resilience. You excel at balancing technical requirements with risk mitigation strategies, ensuring that projects are both secure and successful.
At KBR, you bring a proactive mindset and a strong ability to anticipate and manage risks, safeguarding critical systems and operations. Known for your analytical thinking, problem-solving skills, and ability to collaborate across teams, you thrive in environments where your strategic input ensures the continued success and stability of mission-critical systems.
What You'll DoIn the role of Systems Engineer: Risk Manager, your duties will include:
+ Lead risk assessments and develop risk management plans for systems and projects across various domains.
+ Identify potential risks, threats, and vulnerabilities within system designs and operations.
+ Collaborate with engineering teams to create and implement risk mitigation strategies and solutions.
+ Conduct regular risk reviews and ensure compliance with safety, security, and regulatory standards.
+ Use data analysis tools to evaluate system performance and identify areas for improvement.
+ Communicate risk assessments and mitigation plans to stakeholders and senior leadership.
+ Assist in the development of system architectures and designs with a focus on minimizing risks.
+ Support the creation of contingency plans and disaster recovery procedures to address critical system failures.
+ Stay up to date with industry best practices, standards, and regulatory requirements related to risk management.
Requirements:
+ Must be a US or Australian citizen
+ Must Possess an active US Top Secret/SCI w/ Polygraph or AUS PV Clearance.
+ Bachelor's degree in Systems Engineering, Risk Management, or a related field.
+ Must have 7 years of related experience supporting large systems and sub-systems.
+ Experience in Model Based Systems Engineering (MBSE)
+ Proven experience in systems engineering and risk management.
+ Strong understanding of risk analysis tools and techniques.
+ Expertise in system architecture and lifecycle management.
+ Ability to assess and mitigate technical, operational, and financial risks.
+ Excellent communication and interpersonal skills, with the ability to present technical information to non-technical stakeholders.
+ Detail-oriented with strong analytical and problem-solving skills.
+ Ability to work collaboratively with cross-functional teams and senior leadership.
This role will be located in Alice Springs. This position is expected to be onsite 100%.
#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.

**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

Do you thrive in a fast-paced environment where quality and regulatory compliance are key to success? Are you an ISO 13485 expert with a keen eye for risk and continuous improvement? If so, GN Hearing Australia has the perfect opportunity for you!
We're on the lookout for a **Quality Assurance & Regulatory Affairs Associate** to support and elevate our ANZ operations. You'll play a crucial role in ensuring compliance with regulatory standards and GN's global quality management system - while helping improve lives through advanced hearing solutions.
As our QA/RA Associate, you'll:
+ Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates.
+ Support compliance with ISO13485 and local regulatory standards.
+ Act as the local Subject Matter Expert for quality processes and risk assessments.
+ Conduct internal audits and manage CAPAs, NCs, and quality records.
+ Drive validation activities for custom-manufactured products at our Sydney facility.
+ Collaborate with internal teams and corporate stakeholders across the globe.
+ Train and support teams on quality and regulatory matters.
+ Represent the business in local QA/RA meetings and interactions with TGA and other bodies.
+ Be a key player in a high-performing, values-led QA/RA team.
We're looking for someone who:
+ Has a solid understanding of ISO 13485 and quality systems.
+ Knows their way around internal auditing, CAPA, and validation processes.
+ Is confident, detail-oriented, and self-motivated.
+ Communicates effectively with stakeholders at all levels.
+ Has 3+ years' experience in a QA/RA role, ideally in medical devices.
+ Is a natural problem-solver and thrives in a process-driven environment.
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.
GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history - fostering a sense of community, openness, and understanding.
By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them.
**The GN-owned brands that are responsible for bringing these technologies to life:**
+ Medical grade hearing technology: ReSound ( , Beltone ( , Interton ( , Jabra ( Professional collaboration: Jabra ( , BlueParrott ( , FalCom ( Gaming, calls and media: SteelSeries ( , Jabra ( in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN's solutions are sold in around 100 countries across the world.
If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn ( , Facebook ( and Twitter ( .
We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA+ individuals, and persons with disabilities are encouraged to apply. Come join our team!