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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