Joulé · 17 hours ago
Quality Assurance / Regulatory Affairs (QA/RA) Manager
Jersey City, NJ
Contract
Onsite
Senior Level
$100K/yr - $130K/yr
5+ years expJoulé 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 operations, ensuring compliance with FDA and ISO standards while leading continuous improvement initiatives.
Staffing & Recruiting
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 preferred
PMA, reimbursement experience, and ISO 13485 Lead Auditor certification are a plus
Experience with IQOQPQ a plus
Company
Joulé
At Joulé, we believe our world is filled with possibilities – where character, integrity, and commitment drive our purpose.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase