Regulatory Manager

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


Required Skills

* 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

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Indianapolis, IN



Anticipated Start Date

Monday, February 21, 2022

Job Type

Direct Hire

Anticipated Duration


Date Posted

Wednesday, January 12, 2022

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Elite Technical Services, Inc. participates in the E-Verify program to confirm the employment eligibility of all persons hired. This means that we will provide the Social Security Administration (SSA) and, if necessary, the Department of Homeland Security (DHS), with information from each new employee's Form I-9 to confirm work authorization. Elite Technical Services, Inc. will not use E-Verify to pre-screen job applicants.

Elite Technical Services, Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.