Regulatory Affairs Manager
FTE Permanent Position - 3 openings
MUST HAVE - 510K Experience
This position will support a business critical project to gain premarket approval (PMA) for a Class III IVD in the U.S. The right candidate must have direct experience gaining FDA approvals and/or clearances for IVD (preferred) or medical devices and should have direct experience interfacing with FDA reviewers.
Manage activities associated with regulatory approval of in vitro diagnostic medical devices. Responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Responsible for assessment of device changes for regulatory implications.
Must haves:
Bachelors in Science, Engineering or related field - Advanced degree preferred but not required
Regulatory Affairs Certificate is preferred
MUST have a minimum of 5 years experience in Regulatory.
ABSOLUTELY MUST HAVE experience with 510K Submissions
PMA is ideal.
25% Travel is required.
H1B Transfers will be considered
All travel expenses paid for Interview
Relocation compensation is being offered
Estimated Salary: $20 to $28 per hour based on qualifications.
MUST HAVE - 510K Experience
This position will support a business critical project to gain premarket approval (PMA) for a Class III IVD in the U.S. The right candidate must have direct experience gaining FDA approvals and/or clearances for IVD (preferred) or medical devices and should have direct experience interfacing with FDA reviewers.
Manage activities associated with regulatory approval of in vitro diagnostic medical devices. Responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Responsible for assessment of device changes for regulatory implications.
Must haves:
Bachelors in Science, Engineering or related field - Advanced degree preferred but not required
Regulatory Affairs Certificate is preferred
MUST have a minimum of 5 years experience in Regulatory.
ABSOLUTELY MUST HAVE experience with 510K Submissions
PMA is ideal.
25% Travel is required.
H1B Transfers will be considered
All travel expenses paid for Interview
Relocation compensation is being offered
Estimated Salary: $20 to $28 per hour based on qualifications.
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