LabVine

Product Specialist, Microbiology

LabVine

part-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $40,000 - $46,000 per year

Job Level

Mid-LevelSenior

About the role

  • 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.

Requirements

  • Must reside in the United States.
  • Four-year degree (bachelor’s degree) or diploma in a relevant scientific discipline (e.g., microbiology, chemistry, pharmacy, engineering, or similar).
  • Minimum five years of professional experience in the regulatory review of antimicrobial susceptibility testing IVD devices (including 510(k), PMAs, de novo petitions, pre-submissions).
  • Combination of education and experience may be acceptable (e.g., associate’s degree + 10+ years relevant experience).
  • Desired: Master’s degree or PhD OR bachelor’s degree with additional microbiology certification/specialization (e.g., M(ASCP) or ABMM).
  • Demonstrated experience conducting 510(k) submissions or reviews on behalf of the U.S. FDA with thorough understanding of regulatory requirements.
  • Hands-on laboratory experience using FDA-cleared microbiology-related IVD devices.
  • Practical experience in analytical testing/assessing analytical data and/or participation in clinical studies related to IVDs.