Regulatory Affairs Specialist - Medical Devices (AU)

Narooma; Sydney; Hybrid; AUD 110,000 - 140,000; Full time

Benefits offered by this job

Competitive salary

Flexible benefits package

Job summary

Medtronic in Australia is seeking a Regulatory Affairs Specialist to support regulatory submissions, licenses, and ongoing compliance for medical devices in Australia. This onsite role is based in Macquarie Park, NSW, with no travel required.

Reporting to the Senior Regulatory Affairs Manager, you will coordinate submissions, monitor regulatory changes, maintain licenses, and collaborate with cross-functional teams to ensure market access and patient safety throughout the product lifecycle.

Qualifications

• Bachelor's degree with 2+ years in Regulatory Affairs in healthcare.
• Experience preparing regulatory submissions and license renewals.
• Familiarity with QARA operations and GMP knowledge.
• Proficient with Microsoft Office.

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 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 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.

Skills

Regulatory submissions

QARA operations

Stakeholder collaboration

MS Office

Education

Bachelor's degree in life sciences or related field

Tools

MS Office

Job description

Medtronic in Australia is seeking a Regulatory Affairs Specialist to support regulatory submissions, licenses, and ongoing compliance for medical devices in Australia. This onsite role is based in Macquarie Park, NSW, with no travel required.

Reporting to the Senior Regulatory Affairs Manager, you will coordinate submissions, monitor regulatory changes, maintain licenses, and collaborate with cross-functional teams to ensure market access and patient safety throughout the product lifecycle.