Senior Regulatory Affairs Specialist
1 week ago
Job Description
- As a Senior Regulatory Affairs Associate, you will support a high-priority product portfolio during a critical period of growth. The role is instrumental in ensuring efficient, compliant, and timely pre-market submissions.
About the Opportunity
- This position plays a vital role in regulatory strategy and operations for the ANZ region. You will report to a seasoned Regulatory Affairs Manager and work collaboratively with cross-functional teams, including commercial and market access.
Key Responsibilities
- Manage end-to-end regulatory submissions, including TGA interactions
- Lead regulatory strategy and compile technical files, primarily adapted from EU documentation
- Prepare documentation for high-class devices: Class III IVD, Class IIb, and Class III Medical Devices
- Review local documentation and assess non-conformance where required
- Evaluate the regulatory impact of product and process changes
- Review promotional and advertising materials for compliance
- Provide regulatory support to cross-functional teams
Requirements
- Tertiary qualification in a scientific or healthcare-related discipline
- Minimum 3 years of Regulatory Affairs experience in medical devices
- Strong technical writing experience, especially with regulatory files
- Experience working on TGA submissions and promotional material reviews
- Intelligent, adaptable, and a strong communicator across functions
- Self-motivated, proactive, and capable of managing priorities in a fast-paced setting
Company Benefits
- Work with a global leader in medical technology
- Opportunity to contribute to a high-impact product launch
- Collaborative environment with flexibility and autonomy
About the Company
- Our company is a global healthcare leader renowned for developing innovative, life-changing technologies in medical devices.
- We have a strong presence in Australia and across international markets, committed to improving patient care and advancing the future of healthcare.
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