<p>Description</p> <p>Regulatory Strategy & Leadership</p> <p>Develop and execute global regulatory strategies that support product development, commercialization, and business objectives.</p> <p>Lead the planning, preparation, and submission of regulatory filings across multiple markets, including the United States, European Union, and other international regions.</p> <p>Oversee regulatory submissions such as FDA 510(k), PMA, and IND/IDE applications, as well as EU MDR Technical Documentation and CE Mark activities.</p> <p>Act as the primary regulatory interface with health authorities, notified bodies, and international regulatory agencies.</p> <p>Provide regulatory guidance throughout the product lifecycle, supporting R&D, clinical activities, labeling strategy, manufacturing, and post-market activities.</p> <p>Monitor changes in global regulatory requirements and standards, assess regulatory risk, and proactively communicate potential impacts to stakeholders.</p> <p>Quality System Leadership</p> <p>Design, implement, and maintain a robust Quality Management System.</p> <p>Ensure compliance with applicable regulations and standards, including:</p> <p>FDA 21 CFR Part 820 (including transition to QMSR)</p> <p>ISO 13485</p> <p>EU MDR quality system requirements</p> <p>MDSAP, as applicable</p> <p>Maintain continuous inspection readiness and lead preparation for FDA inspections and notified body audits.</p> <p>Oversee and improve core quality processes, including:</p> <p>Corrective and Preventive Actions (CAPA)</p> <p>Complaint handling and post-market surveillance, including vigilance reporting</p> <p>Nonconformance and deviation management</p> <p>Document control and training systems</p> <p>Lead risk management activities in accordance with ISO 14971.</p> <p>Establish and manage supplier qualification and supplier quality oversight programs.</p> <p>Develop and deliver quality and regulatory training programs to promote organizational understanding and compliance.</p> <p>EU MDR / CE Mark Oversight</p> <p>Own the strategy and execution for EU MDR compliance, including notified body engagement and audit readiness.</p> <p>Ensure continued CE Mark compliance as products evolve and regulations change.</p> <p>Skills & Qualifications</p> <p>Bachelor's degree in Life Sciences, Engineering, or related technical field</p> <p>7+ years of progressive Regulatory Affairs and/or Quality Assurance experience in medical devices, biotech, wound care, or combination products</p> <p>3+ years in a formal leadership role</p> <p>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)</p> <p>Experience supporting products from development through commercialization</p> <p>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</p> <p>Preferred</p> <p>Advanced degree: Masters or PhD</p> <p>RAC and/or ASQ certifications (CQA, CQE).</p> <p>Prior experience with biomaterials, wound care, antimicrobial technologies, or combination products.</p> <p>Job Type & Location</p> <p>This is a Permanent position based out of Middleton, WI.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $100000.00 - $150000.00/yr.</p> <p>Medical, Dental, Vision 401K Match Competitive benefits and PTO</p> <p>Workplace Type</p> <p>This is a fully onsite position in Middleton,WI.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Apr 23, 2026.</p> <p>Diversity, Equity & Inclusion</p> <p>At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:</p> <ul> <li>Hiring diverse talent </li><li>Maintaining an inclusive environment through persistent self-reflection </li><li>Building a culture of care, engagement, and recognition with clear outcomes </li><li>Ensuring growth opportunities for our people </li></ul> <p>Actalent is an equal opportunity employer.</p> <p>About Actalent</p> <p>Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.</p> <p>Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.</p>