This is an opportunity to work for a global medical devices organization and is intended to provide full ongoing compliance and new submissions to support to all applicable FDA medical device regulatory requirements. Patient-focused for over two decades, they're looking for progression-driven individuals to join their exciting regulatory function at their corporate HQ!
Duties and responsibilities
- Perform Pre-Market U.S. FDA 510(k) submissions in accordance with the product plan and regulatory strategy
- Provide feedback and recommendations to design teams regarding deciding when to submit a 510(k) for a change to an existing medical device
- Coordinate all Mandatory Field Notifications, Engineering Change Orders, and Correction and Removals, take appropriate action and maintain all records
- Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action
- Perform Corrective and Preventive Action activities
- Bachelor Degree highly preferred
- 5 or more years of hands on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment
- Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) and U.S. FDA import/export/customs regulations
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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