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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