QA/RA Manager - Medical Device Manufacturing (PRP Products) 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. Regulatory Affairs + 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. Cross-Functional Leadership + 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. Required Qualifications + 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 Is this job for you? + 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 #M3- #LI- #DI- Ref: #562-Joule Staffing - Edison System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.