Inspection Consultant Job at Meet Life Sciences, Charlotte, NC

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  • Meet Life Sciences
  • Charlotte, NC

Job Description

*1 week assignment on-site in Charlotte, NC*

Job Summary:

We are seeking an experienced Pre-Approval Inspection (PAI) Consultant to support FDA inspection readiness for a medical device company preparing for pre-market approval. The ideal candidate will have deep expertise in FDA 21 CFR Part 820 , GMP compliance , and pre-market approval (PMA) processes.

Responsibilities:

  • Lead inspection readiness efforts in preparation for FDA pre-approval inspections (PAIs)
  • Conduct gap assessments and mock audits against FDA QSR (21 CFR Part 820) and GMP standards
  • Review and strengthen quality systems, documentation, and procedures
  • Develop and implement corrective and preventive actions (CAPAs)
  • Train internal teams on inspection protocol and regulatory expectations

Qualifications:

  • Bachelor’s degree in life sciences, engineering, or a related field
  • Minimum 8 years’ experience in medical device quality, regulatory, or compliance roles
  • Strong knowledge of FDA GMP requirements and 21 CFR Part 820
  • Proven success supporting PMA and FDA inspection readiness initiatives

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