Regulatory Affairs Specialist

About the role

Medtronic's Regulatory Affairs function supports the registration, licensing and ongoing regulatory compliance of medical devices across the Australian market. This Specialist role is based in Macquarie Park, New South Wales, on an onsite basis with no travel required, and reports to the Senior Regulatory Affairs Manager. It covers a portfolio of medical devices in Australia.

Key responsibilities

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

Required profile

• 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.
• Experience partnering with internal and external stakeholders to achieve compliance objectives.
• Preferred: Bachelor's degree in Medical Science, Biological Science or a related life science discipline.
• Preferred: experience with medical device registrations, GMP-regulated environments, Australian regulatory requirements and multiple product portfolios.

Required skills

• Proficiency in Microsoft Office applications.

The employer also warns against recruitment fraud and asks candidates to apply only through official Medtronic channels.