Inspection Consultant

1 week assignment on-site in Charlotte, NCJob **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.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 standardsReview and strengthen quality systems, documentation, and proceduresDevelop and implement corrective and preventive actions (CAPAs)Train internal teams on inspection protocol and regulatory expectations***Bachelor's degree in life sciences, engineering, or a related fieldMinimum 8 years' experience in medical device quality, regulatory, or compliance rolesStrong knowledge of FDA GMP requirements and 21 CFR Part 820Proven success supporting PMA and FDA inspection readiness initiatives

Created: 2025-06-09