Quality Assurance & Regulatory Affairs Manager
Jersey City, New Jersey
Experience: 0
Category: Scientific & Clinical
Contractor Work Model: Onsite
Brand: Joulé
Compensation Range: 100000.00 - 130000.00
Job ID: 345832
Date Posted: 03/24/2026
Shortcut: http://jobs.systemone.com/tilJqe
Quality Assurance & Regulatory Affairs Manager - Medical Device Manufacturing (PRP Products)
Location: Jersey City, NJ
Hours / Schedule: Onsite, Monday - Friday
Type: Direct Hire
Compensation: $100,000 – $130,000 annually
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 Quality Assurance & Regulator Affairs (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.
Responsibilities
Quality Management
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Own, maintain, and continuously improve the Quality Management System (QMS) in accordance with 21 CFR Part 820, ISO 13485, and MDSAP.
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Oversee QC laboratory activities, including QC testing, environmental monitoring, LAL endotoxin testing, bioburden/microbiology monitoring, and QC documentation.
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Serve as the company’s primary Quality contact for FDA, ISO, MDSAP, and customer audits.
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Manage CAPAs, deviations, complaints, nonconformances, risk management, and change controls.
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Lead internal audits, audit readiness, and continuous improvement initiatives.
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Oversee document control, training programs, and supplier qualification.
Regulatory Affairs
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Act as the company’s FDA & MDSAP subject matter expert.
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Develop and execute regulatory strategies for new and existing products.
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Prepare, submit, and maintain 510(k) submissions; PMA and reimbursement experience are a plus.
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Maintain registrations, listings, regulatory documentation, and communication with regulatory agencies.
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Review labeling, claims, and promotional materials for compliance.
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Support design control and product development from a regulatory standpoint.
Cross-Functional Leadership
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Provide QA/RA oversight and guidance for production, operations, warehouse, and product development teams.
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Lead investigations and root-cause analysis to ensure robust quality decision-making.
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Support QA/RA across RegenLab USA and RegenSkin LLC.
Requirements
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Bachelor’s Degree in Life Sciences, Engineering, Regulatory Affairs, or related field.
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5–7 years QA/RA experience in medical device manufacturing.
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Strong working knowledge of 21 CFR 820, FDA regulations, and ISO 13485.
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Direct experience supporting FDA inspections and MDSAP audits.
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Hands-on experience managing key QMS processes in a small or mid-sized company.
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Experience preparing and maintaining FDA 510(k) submissions.
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Excellent communication, documentation, and organizational skills.
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Experience with PRP, regenerative medicine, or biologics - adjacent products preferred.
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PMA, reimbursement experience, and ISO 13485 Lead Auditor certification are a plus.
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Experience with IQOQPQ a plus
Is this job for you?
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High-impact, hands-on leadership role
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Direct access to executive leadership
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Opportunity to build, shape, and elevate the QA/RA function
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Work in a rapidly growing, innovative regenerative medicine environment
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Full-time on-site stability-no travel required
#M3
Ref: #558-Scientific
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