Quality Assurance / Regulatory Affairs (QA/RA) Manager

We are a medical device manufacturing company specializing in PRP products, seeking a hands-on QA/RA Manager to lead Quality and Regulatory functions in a fast-paced, small-company environment. The role serves as the FDA and MDSAP subject matter expert, supporting day-to-day manufacturing, quality operations, and regulatory submissions. This is a full-time, on-site position based in our Jersey City, NJ facility. Key Responsibilities: - Own and maintain the QMS in compliance with 21 CFR Part 820, ISO 13485, and MDSAP - Serve as primary Quality contact for FDA, MDSAP, ISO, and customer audits - Manage CAPAs, deviations, complaints, risk management, change control, and internal audits - Oversee document control, training, and supplier qualification - Support production, warehouse, and operations teams with quality oversight - Lead investigations, root cause analysis, and audit readiness - Act as the company’s FDA and MDSAP expert - Develop and implement regulatory strategies for new and existing products - Prepare and maintain 510(k), PMA (plus), and reimbursement filings (plus) - Interface with FDA and other regulatory agencies - Maintain registrations, listings, and regulatory records - Monitor regulatory changes and assess impact - Review labeling, promotional materials, and claims for compliance - Provide guidance throughout product development and design control - Oversee QA/RA support across RegenLab USA and RegenSkin LLC.