Quality Assurance / Regulatory Affairs (QA/RA) Manager
Location: Jersey City, NJ
Employment Type: Direct Hire
Compensation: $100,000 – $130,000 annually
Schedule: On-site, Monday–Friday
Reports to: President & CEO About the Role
This role is with a new employer in the area, a growing medical device manufacturer specializing in PRP technologies and regenerative products. We’re seeking a hands-on, proactive QA/RA Manager who thrives in a fast-paced, small-company environment and is ready to take ownership of Quality, Regulatory, and QC Laboratory oversight , including QC microbiology testing, LAL endotoxin testing, and overall QC compliance activities . This role is ideal for a driven leader who wants full visibility, autonomy, and impact across manufacturing, regulatory strategy, audits, and day-to-day quality operations . Key Responsibilities
Quality Management
- Own, maintain, and continuously improve the Quality Management System (QMS) in accordance with 21 CFR Part 820 , ISO 13485 , and MDSAP .
- Oversee QC laboratory activities , including QC testing, environmental monitoring, LAL endotoxin testing, bioburden/microbiology monitoring , and QC documentation.
- Serve as the company’s primary Quality contact for FDA, ISO, MDSAP , and customer audits.
- Manage CAPAs, deviations, complaints, nonconformances, risk management , and change controls .
- Lead internal audits , audit readiness, and continuous improvement initiatives.
- Oversee document control , training programs, and supplier qualification.
- Act as the company’s FDA & MDSAP subject matter expert .
- Develop and execute regulatory strategies for new and existing products.
- Prepare, submit, and maintain 510(k) submissions ; PMA and reimbursement experience are a plus.
- Maintain registrations, listings, regulatory documentation , and communication with regulatory agencies.
- Review labeling, claims, and promotional materials for compliance.
- Support design control and product development from a regulatory standpoint.
- Provide QA/RA oversight and guidance for production, operations, warehouse , and product development teams.
- Lead investigations and root-cause analysis to ensure robust quality decision-making.
- Support QA/RA across RegenLab USA and RegenSkin LLC .
- Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs , or related field.
- 5–7 years QA/RA experience in medical device manufacturing .
- Strong working knowledge of 21 CFR 820 , FDA regulations, and ISO 13485.
- Direct experience supporting FDA inspections and MDSAP audits .
- Hands-on experience managing key QMS processes in a small or mid-sized company.
- Experience preparing and maintaining FDA 510(k) submissions .
- Excellent communication, documentation, and organizational skills.
- Experience with PRP, regenerative medicine , or biologics-adjacent products preferred.
- PMA, reimbursement experience, and ISO 13485 Lead Auditor certification are a plus.
- Experience with IQOQPQ a plus
- High-impact, hands-on leadership role
- Direct access to executive leadership
- Opportunity to build, shape, and elevate the QA/RA function
- Work in a rapidly growing, innovative regenerative medicine environment
- Full-time on-site stability-no travel required
#LI-
#DI- Ref: #558-Scientific
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