System One · 8 hours ago
Quality Assurance / Regulatory Affairs (QA/RA) Manager
Jersey City, NJ
Contract
Onsite
Senior Level
$100K/yr - $130K/yr
5+ years expSystem One is a growing medical device manufacturer specializing in PRP technologies and regenerative products. They are seeking a hands-on, proactive QA/RA Manager to oversee Quality, Regulatory, and QC Laboratory activities, ensuring compliance with FDA and ISO standards while leading internal audits and regulatory strategies.
Staffing Agency
Responsibilities
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
Qualification
Required
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
Preferred
Experience with PRP, regenerative medicine, or biologics-adjacent products
PMA, reimbursement experience, and ISO 13485 Lead Auditor certification
Experience with IQOQPQ
Company
System One
System One is a professional staffing firms.
5001-10000 employees
H1B Sponsorship
System One has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (6)
2023 (9)
2022 (10)
2021 (9)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
$301.8MKey Investors
TruistOaktree Capital ManagementProspect Capital Corporation
2021-01-28Debt Financing· $290M
2020-12-08Private Equity
2016-09-20Acquired
Leadership Team
Troy Gregory
Chief Executive Officer
Dan Moran
Chief Financial Officer
Recent News
2026-01-06
Company data provided by crunchbase