Quality Assurance Manager

We’re supporting a market leader in the regenerative medicine space. They’re looking for a hands‑on QA/RA Manager to take ownership of Quality and Regulatory operations across the organization.

If you thrive in a fast-paced setting where your expertise directly shapes product quality, compliance, and regulatory strategy, this is a fantastic opportunity.

• Leading and maintaining the QMS across 21 CFR Part 820, ISO 13485, and MDSAP
• Acting as the primary contact for FDA, MDSAP, ISO, and customer audits
• Overseeing document control, training, and supplier qualification
• Supporting manufacturing, warehouse, and operations teams with quality oversight
• Driving investigations, RCA, audit readiness, and continuous improvement
• Leading regulatory strategy for both existing and new products
• Preparing and maintaining 510(k) submissions (PMA and reimbursement experience a plus)
• Reviewing labeling, claims, and promotional materials
• Supporting product development and design control activities.

• 5+ years of QA/RA experience in medical device manufacturing
• Proven knowledge of 21 CFR Part 820 and FDA regulations
• Hands‑on experience with FDA inspections & MDSAP audits
• Experience managing QMS elements in small/mid‑sized companies
• 510(k) submission experience (PMA is a bonus)
• Background in PRP, regenerative medicine, or biologics
• ISO 13485 Lead Auditor certification is a plus.

If you are qualified, interested, and would like to find out more, please reach me at