Quality Regulatory Manager

X4 Life Sciences; New Jersey; On-site; USD 90,000 - 120,000; Full time

Job summary

A market leader in regenerative medicine is seeking a hands-on QA/RA Manager to lead Quality and Regulatory operations in New Jersey. The role requires 5+ years of QA/RA experience in medical device manufacturing, oversight of QMS in compliance with FDA regulations, and successful handling of audits. You'll drive regulatory strategies while ensuring product quality in a fast-paced environment. Interested candidates should reach out via email.

Qualifications

• 5+ years of QA/RA experience in medical device manufacturing.
• Proven knowledge of FDA regulations and 21 CFR Part 820.
• Hands-on experience with FDA inspections and MDSAP audits.

Responsibilities

• Lead and maintain the QMS according to regulatory standards.
• Act as primary contact for audits with the FDA and other entities.
• Oversee document control and training within the organization.
• Drive investigations and lead continuous improvement initiatives.
• Prepare and maintain 510(k) submissions for products.

Skills

QA/RA experience in medical device manufacturing

Knowledge of 21 CFR Part 820

Hands-on experience with FDA inspections

Experience with MDSAP audits

Managing QMS elements

510(k) submission experience

Background in regenerative medicine

ISO 13485 Lead Auditor certification

Job description

We’re supporting a market leader in the regenerative medicine space. They’re looking for a hands‑on QA/RA Manager to take ownership of Quality and Regulatory operations across the organization.

If you thrive in a fast‑paced setting where your expertise directly shapes product quality, compliance, and regulatory strategy, this is a fantastic opportunity.

🔍 What You’ll Be Doing

You’ll be the company’s key Quality and Regulatory leader, overseeing everything from day‑to‑day operations to high‑level compliance strategy, including:

• Leading and maintaining the QMS across 21 CFR Part 820, ISO 13485, and MDSAP
• Acting as the primary contact for FDA, MDSAP, ISO, and customer audits
• Overseeing document control, training, and supplier qualification
• Supporting manufacturing, warehouse, and operations teams with quality oversight
• Driving investigations, RCA, audit readiness, and continuous improvement
• Leading regulatory strategy for both existing and new products
• Preparing and maintaining 510(k) submissions (PMA and reimbursement experience a plus)
• Reviewing labeling, claims, and promotional materials
• Supporting product development and design control activities.

🎓 Who They’re Looking For

• 5+ years of QA/RA experience in medical device manufacturing
• Proven knowledge of 21 CFR Part 820 and FDA regulations
• Hands‑on experience with FDA inspections & MDSAP audits
• Experience managing QMS elements in small/mid‑sized companies
• 510(k) submission experience (PMA is a bonus)
• Background in PRP, regenerative medicine, or biologics
• ISO 13485 Lead Auditor certification is a plus.

If you are qualified, interested, and would like to find out more, please reach me at [e-mail].