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Senior Regulatory Affairs Specialist
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Full-time
- StimLabs is looking to hire a Senior Regulatory Affairs Specialist to join our Regulatory team.
- Although this person does not have to work out of our Roswell, GA office, ideally this person would be able to come into the office a minimum of one day a week.
- Provide leadership during development of regulatory submissions (e.g. RFD, 510(k), eSTAR, Q Submission, TRG, IND/CTA, BLA, RMAT, FOIA, etc.)
- Represent Regulatory Affairs department in Change Control meetings to ensure applicable design elements are maintained and not deleted by the change, and to ensure that regulatory classification of the subject product/device is not impacted by the change, or if the regulatory classification is impacted by the change, that the appropriate regulatory justification is provided including submission of a new pre-marketing application, if necessary.
- Under the direction of Management, correspond with regulatory agencies as required including set up and maintenance of Electronic Submissions Gateway (ESG), Customer Collaboration Portal (CDRH Portal), or any other method of transmitting information and corresponding with a regulatory agency.
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