Elite Technical is in search of a Regulatory Manager for one of its global medical device clients. The successful candidate will be positioned to own and grow the complete regulatory process for multiple lines of products.
This individual will be responsible for:
* Ensuring that regulatory requirements are effectively established and maintained in accordance with applicable requirements.
* Ensuring that regulatory actions are evaluated based on the Risk Assessment.
* Obtaining registration approval in desired markets
* BS Degree
* Minimum 5 years experience
* Medical Device experience
* pre-market experience: 510ks/Registration/Tech documentation
* post market experience: Vigilance/Recalls
(+) New Product Development: New Requirements/Regulatory Evaluation of changes
(+) Clinical: Post-Market surveillance/Clinical Evaluation Reports
Monday, February 21, 2022
Wednesday, January 12, 2022
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