Regulatory Affairs Specialist
3 weeks ago
About the Role
Stryker is seeking a highly skilled Regulatory Affairs Specialist to join its regulatory team in Australia. As a Senior Regulatory Affairs Associate, you will be responsible for preparing and submitting device registration applications, reviewing change notifications, and providing strategic regulatory advice.
Key Responsibilities:
- Prepare and submit device registration applications, including Class III and TGA conformity assessment applications.
- Review and determine the impact of change notifications for existing devices.
- Provide strategic regulatory advice and transfer management for product acquisitions.
- Work closely with stakeholders to process regulatory actions in accordance with TGA, Medsafe, and Corporate requirements.
Requirements:
- Minimum 5 years' experience in Regulatory Affairs.
- Tertiary education in a technical discipline (e.g., Science, Engineering, Biomedical).
- High attention to detail and deadline-oriented.
- Self-driven, strategic thinker with experience in Regulatory Affairs.
- Strong knowledge of Medical Device regulations in Australia and New Zealand.
What We Offer:
We offer a competitive salary range of $120,000 - $150,000 per annum, depending on experience, as well as opportunities for professional growth and development in a fast-paced environment.
About Stryker:
Stryker is a rapidly growing company with a high-performing regulatory team. The ideal candidate will have experience with Class III and TGA conformity assessment applications and be able to thrive in a dynamic environment.
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