Regulatory Affairs Specialist, Medical Devices (Australia)

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

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