Regulatory Affairs Specialist

Medtronic plc; Sydney; On-site; AUD 80,000 - 110,000; Full time

Job summary

Medtronic is seeking a Regulatory Affairs Specialist in Macquarie Park, New South Wales, Australia. The role supports regulatory submissions, licensing, and ongoing compliance for Australian medical devices, partnering with global and local stakeholders to ensure market access and patient safety.

Reporting to the Senior Regulatory Affairs Manager, you will prepare submissions, monitor requirements, maintain licenses, and help navigate Australian regulatory authorities while aligning with quality

Qualifications

• Bachelor's degree and 2+ years of Regulatory Affairs experience in healthcare.
• Experience preparing regulatory submissions, registrations, or license renewals.
• Working knowledge of QA and regulatory affairs (QARA) operations.
• Proficiency in Microsoft Office applications.

Responsibilities

• Prepare and coordinate regulatory submission packages for registrations, licensing, audits.
• Compile and maintain documentation for submissions, license renewals, registrations.
• Assess regulatory requirements and advise on labeling, manufacturing, marketing, and clinical activities.
• Monitor regulatory changes and communicate impacts to stakeholders.
• Maintain regulatory tracking and document control systems.
• Support interactions with regulatory authorities and respond to requests.
• Contribute to regulatory strategies for timely approvals and market access.
• Collaborate with cross-functional teams to ensure lifecycle compliance.

Skills

Regulatory Affairs

Healthcare Industry

Stakeholder Engagement

Microsoft Office

Education

Bachelor's degree in Life Sciences

Tools

Regulatory Submissions

Documentation Management

Quality Assurance

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Regulatory Affairs function supports the registration, licensing, and ongoing regulatory compliance of medical devices across the Australian market. The team partners with global and local stakeholders to ensure products meet applicable regulatory requirements, maintain market access, and support patient safety throughout the product lifecycle. This position is based in Macquarie Park, New South Wales, Australia and follows an Onsite work arrangement. No travel is required for this role. Reporting to the Senior Regulatory Affairs Manager, the Regulatory Affairs Specialist supports regulatory activities for a portfolio of medical devices in Australia. The role is responsible for preparing regulatory submissions, maintaining licenses and registrations, monitoring regulatory requirements, and partnering with internal stakeholders to ensure ongoing compliance with applicable regulations and quality standards.

Primary Responsibilities

• Prepare and coordinate regulatory submission packages for product registrations, licensing activities, audits, and inspections.
• Compile and maintain documentation required for submissions, license renewals, and annual registrations.
• Assess regulatory requirements and recommend actions to support compliance for product labeling, manufacturing, marketing, and clinical activities.
• Monitor regulatory changes and communicate potential business impacts to relevant stakeholders.
• Maintain and improve regulatory tracking and document control systems.
• Support interactions with regulatory authorities and respond to regulatory requests as required.
• Contribute to regulatory strategies that support timely product approvals and market access.
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.

Required Qualifications

• Bachelor's degree and 2+ years of experience in Regulatory Affairs within the healthcare industry.
• Experience preparing and managing regulatory submissions, registrations, or license renewals.
• Working knowledge of Quality Assurance and Regulatory Affairs (QARA) operations.
• Proficiency in Microsoft Office applications.
• Experience partnering with internal and external stakeholders to achieve compliance objectives.

Preferred Qualifications

• Bachelor's degree in Medical Science, Biological Science, or a related life sciences discipline.
• Experience with medical device product registrations and licensing activities.
• Experience working within Good Manufacturing Practice (GMP) regulated environments.
• Knowledge of Australian medical device regulatory requirements and regulatory authority interactions.
• Experience supporting regulatory activities across multiple product portfolios.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.