Senior Regulatory Affairs Specialist
15 hours ago
We are seeking a highly experienced Senior Regulatory Affairs Specialist to join our team in Melbourne, Australia. This is an exciting opportunity for a talented professional to work with a leading global medical device company.
The successful candidate will have a minimum of 5 years' experience in regulatory affairs, with a strong understanding of medical device regulations in Australia and New Zealand. International regulatory knowledge, particularly in the US and EU, is also desirable.
About the RoleThis is a senior-level role that requires strategic thinking, excellent communication and negotiation skills, and the ability to thrive in a fast-paced environment. The ideal candidate will be responsible for preparing and submitting device registration applications, including complex submissions such as Class III and/or TGA Conformity Assessment applications.
The Senior Regulatory Affairs Specialist will also provide strategic regulatory advice and transfer management for smooth incorporation of product acquisitions. They will work closely with key stakeholders to process regulatory actions in accordance with the Therapeutic Goods Administration (TGA), Medsafe, and Corporate requirements.
Responsibilities- Prepare and submit device registration applications, including complex submissions.
- 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.
- Manage annual reports and renewals of licenses to ensure compliance.
To be successful in this role, you will need:
- A minimum of 5 years' experience in regulatory affairs.
- Tertiary education in a technical discipline (e.g. Science, Engineering, Biomedical or related).
- High attention to detail and deadline-oriented.
- Self-driven, strategic thinker with excellent communication and negotiation skills.
As a Senior Regulatory Affairs Specialist at Stryker Australia Pty Ltd, you can expect a competitive salary package, including:
- A base salary of AU$120,000 - AU$150,000 per annum.
- A comprehensive benefits package, including health insurance, superannuation, and paid parental leave.
- A Leader who will support and guide you throughout your career.
- Access to our career and self-development program from day one.
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