Danaher·3 months ago
3 months ago
Principal, RA Specialist
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About this role
Become part of our team as a Principal, RA Specialist, driving the global introduction of new and modified IVD medical devices and software. Lead regulatory submissions, collaborate internationally, and mentor associates. Ideal for experienced regulatory professionals with expertise in in vitro diagnostics and global regulatory environments.
Skills
- regulatory submissions
- ivd regulations
- pma submission
- 510(k) submission
- technical file submission
- risk management
- iso 13485
- ivdr
- 21 cfr part 820
- product development process
- regulatory assessment
- mentorship
- collaborative facilitation
- stakeholder management
- analytical skills
Company
Danaher
New York, United States of America
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