LabVine

Product Specialist

• Lead Reviewer on premarket 510(k) submissions eligible for review by an FDA-recognized Third Party Review Organization.
• Coordinate technical review of low-to-moderate risk medical devices; evaluate analytical and clinical performance data for safety, effectiveness, and labeled claims.
• Analyze and interpret regulations, FDA guidance documents, and voluntary consensus standards related to medical devices.
• Communicate technical and regulatory recommendations via memoranda and presentations; draft Additional Information Letters and review recommendation memoranda in accordance with 21 CFR 10.70.
• Communicate review questions and clarifications with 510(k) submitters during Substantive Interaction; assess adequacy of responses and document all interactions.
• Formulate review teams including external technical experts; manage consultations and review timelines; work with Project Manager to submit reviews to FDA.
• Keep abreast of evolving regulatory policies and best practices; complete maintenance training and pursue professional development; identify process improvements.

Product Specialist, Microbiology