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Quality Assurance / Regulatory Affairs (QA/RA) Manager

Joulé

Jersey City, NJ

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JOB DETAILS
SALARY
$100,000–$130,000 Per Year
SKILLS
Auditing, Biology, Change Control, Code of Federal Regulations, Communication Skills, Continuous Improvement, Cross-Functional, Document Control, Documentation, Environmental Monitoring, FDA (Food and Drug Administration), FDA Requirements, ISO (International Organization for Standardization), Insurance Regulations, Internal Audit, Laboratory Management, Leadership, Manufacturing, Manufacturing Management, Manufacturing Requirements, Medical Equipment, Medicine, Microbiology, Organizational Skills, Process Management, Product Design, Product Development, Quality Assurance, Quality Control, Quality Management, Regulations, Reimbursement, Risk Management, Root Cause Analysis, Small Company, Testing, Training Program, Warehousing
LOCATION
Jersey City, NJ
POSTED
3 days ago
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: #558-Scientific


About the Company

J

Joulé

With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:

  • Scientific staffing for hard-to-find skills

Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.

  • Clinical lifecycle recruiting

From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.

  • Equipment calibration, maintenance and validation

Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.

  • National healthcare recruitment

Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
WEBSITE
https://www.jouleinc.com/