Director Of Quality Assurance And Regulatory Affairs
Actalent, West Middleton, WI, United States
Responsibilities
Regulatory Strategy & Leadership: Develop and execute global regulatory strategies that support product development, commercialization, and business objectives. Lead the planning, preparation, and submission of regulatory filings across multiple markets, including the United States, European Union, and other international regions. Oversee regulatory submissions such as FDA 510(k), PMA, and IND/IDE applications, as well as EU MDR Technical Documentation and CE Mark activities. Act as the primary regulatory interface with health authorities, notified bodies, and international regulatory agencies. Provide regulatory guidance throughout the product lifecycle, supporting R&D, clinical activities, labeling strategy, manufacturing, and post‑market activities. Monitor changes in global regulatory requirements and standards, assess regulatory risk, and proactively communicate potential impacts to stakeholders.
Quality System Leadership: Design, implement, and maintain a robust Quality Management System. Ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 820 (transition to QMSR), ISO 13485, EU MDR quality system requirements, and MDSAP, as applicable. Maintain continuous inspection readiness and lead preparation for FDA inspections and notified‑body audits. Oversee and improve core quality processes, including Corrective and Preventive Actions (CAPA), complaint handling, post‑market surveillance and vigilance reporting, nonconformance and deviation management, document control, and training systems. Lead risk‑management activities in accordance with ISO 14971. Establish and manage supplier qualification and supplier‑quality oversight programs. Develop and deliver quality and regulatory training programs to promote organizational understanding and compliance.
EU MDR / CE Mark Oversight: Own the strategy and execution for EU MDR compliance, including notified‑body engagement and audit readiness. Ensure continued CE Mark compliance as products evolve and regulations change.
Qualifications Bachelor’s degree in Life Sciences, Engineering, or a related technical field. 7+ years of progressive Regulatory Affairs and/or Quality Assurance experience in medical devices, biotech, wound care, or combination products. 3+ years in a formal leadership role. Demonstrated success leading multiple U.S. and EU regulatory submissions, including FDA (510(k), De Novo, PMA, and/or combination products) and CE Marking under EU MDR (2017/745). Experience supporting products from development through commercialization. Expertise in FDA regulations (21 CFR Parts 210, 211, 820), EU MDR, ISO 13485, ISO 14971, design controls, risk management, and clinical and post‑market regulatory requirements, including hands‑on interaction with FDA and Notified Bodies. Preferred advanced degree: Masters or PhD. RAC and/or ASQ certifications (CQA, CQE). Prior experience with biomaterials, wound care, antimicrobial technologies, or combination products.
Skills Regulatory Affairs, Regulatory, Medical Device, Regulatory Submission, FDA, Quality Assurance, ISO 13485, Supplier Quality, Regulatory Compliance, Regulatory Documents, GMP.
Compensation & Benefits The pay range for this position is $100,000.00 – $150,000.00 per year. Medical, Dental, Vision, 401(k) Match, competitive benefits, and PTO.
Location Permanent position based out of Middleton, WI. Fully onsite.
EEO & Diversity Statement
Hiring diverse talent
Maintaining an inclusive environment through persistent self‑reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
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Quality System Leadership: Design, implement, and maintain a robust Quality Management System. Ensure compliance with applicable regulations and standards, including FDA 21 CFR Part 820 (transition to QMSR), ISO 13485, EU MDR quality system requirements, and MDSAP, as applicable. Maintain continuous inspection readiness and lead preparation for FDA inspections and notified‑body audits. Oversee and improve core quality processes, including Corrective and Preventive Actions (CAPA), complaint handling, post‑market surveillance and vigilance reporting, nonconformance and deviation management, document control, and training systems. Lead risk‑management activities in accordance with ISO 14971. Establish and manage supplier qualification and supplier‑quality oversight programs. Develop and deliver quality and regulatory training programs to promote organizational understanding and compliance.
EU MDR / CE Mark Oversight: Own the strategy and execution for EU MDR compliance, including notified‑body engagement and audit readiness. Ensure continued CE Mark compliance as products evolve and regulations change.
Qualifications Bachelor’s degree in Life Sciences, Engineering, or a related technical field. 7+ years of progressive Regulatory Affairs and/or Quality Assurance experience in medical devices, biotech, wound care, or combination products. 3+ years in a formal leadership role. Demonstrated success leading multiple U.S. and EU regulatory submissions, including FDA (510(k), De Novo, PMA, and/or combination products) and CE Marking under EU MDR (2017/745). Experience supporting products from development through commercialization. Expertise in FDA regulations (21 CFR Parts 210, 211, 820), EU MDR, ISO 13485, ISO 14971, design controls, risk management, and clinical and post‑market regulatory requirements, including hands‑on interaction with FDA and Notified Bodies. Preferred advanced degree: Masters or PhD. RAC and/or ASQ certifications (CQA, CQE). Prior experience with biomaterials, wound care, antimicrobial technologies, or combination products.
Skills Regulatory Affairs, Regulatory, Medical Device, Regulatory Submission, FDA, Quality Assurance, ISO 13485, Supplier Quality, Regulatory Compliance, Regulatory Documents, GMP.
Compensation & Benefits The pay range for this position is $100,000.00 – $150,000.00 per year. Medical, Dental, Vision, 401(k) Match, competitive benefits, and PTO.
Location Permanent position based out of Middleton, WI. Fully onsite.
EEO & Diversity Statement
Hiring diverse talent
Maintaining an inclusive environment through persistent self‑reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
#J-18808-Ljbffr