Senior Manager, Regulatory Affairs

Your Career. Your Impact. Your Future. At Gentherm, we believe the next big breakthrough begins with you. As a global leader in thermal management and pneumatic comfort technologies, we develop advanced systems that deliver meaningful solutions to enhance health, wellness, comfort, and efficiency in everyday life. Our products and innovations are created for you, by you. Be part of our team where a human-centric mindset drives everything we do—from the technologies we build to the careers we support. With decades of expertise, we have pioneered advanced solutions that have become a standard expectation for consumers around the world. The same thoughtful approach we take in developing our technologies guides how we support your career: purposeful, impactful, and tailored to you. Because when you thrive, innovation thrives. Global Senior Manager, Regulatory Affairs The Global Senior Manager, Regulatory Affairs serves as the senior regulatory leader for Gentherm Medical, responsible for developing and executing regulatory strategies that support global market access, product lifecycle management, and business growth. This role partners closely with executive leadership to assess regulatory risks and opportunities, provides strategic guidance on regulatory matters, and leads interactions with global regulatory authorities. The position oversees the Regulatory Affairs function and ensures compliance with applicable global regulations. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES Lead the development and execution of regulatory strategies for new product introductions, market expansions, and product lifecycle management. Serve as the primary liaison with FDA, MHRA, EMA, NMPA, Health Canada, and other global regulatory bodies, representing Gentherm Medical in negotiations, high-stakes escalations, and agency interactions. Direct global regulatory compliance activities including 510(k) submissions, international registrations, complaint handling, MDR, corrections and removals, and post-market surveillance. Lead regulatory intelligence efforts globally - monitoring emerging regulatory trends (e.g., EU MDR, China NMPA, LATAM registrations) and proactively advising executive leadership on strategic implications. Partner with Product Management, R&D, Clinical, Quality, Legal, Supply Chain, and Commercial teams to embed regulatory strategy into business planning, early concept review, and product lifecycle management. Influence decision-making on product classifications, regulatory pathways, and reimbursement strategies to optimize commercial outcomes. Oversee preparation and submission of global regulatory filings and formal correspondence with agencies. Host and lead global regulatory audits and inspections (FDA, ISO, Notified Body, Product Safety), ensuring Gentherm Medical maintains strong audit readiness with executive-level oversight. Lead and oversee corrective action and remediation plans resulting from regulatory inspections, ensuring timely closure and communication to agencies and customers. Develop, implement, and continuously refine global regulatory policies, systems, and governance structures that support compliance and scalability. Champion regulatory training and executive-level awareness programs to build organizational competence and proactive compliance culture Support strategic initiatives including M&A regulatory assessments, new product introduction strategy, and cross-functional regulatory risk reviews. MINIMUM QUALIFICATIONS Bachelor’s degree required; advanced degree preferred. Minimum 7 years of regulatory affairs leadership experience in the medical device or pharmaceutical industry. Minimum 3 years of leadership or people management experience. Experience preparing and supporting regulatory submissions and product registrations in multiple global markets. PREFERRED QUALIFICATIONS RAC Certification or equivalent. Experience representing an organization during regulatory escalations or high-impact inspections Strong knowledge of U.S. FDA regulations, EU MDR, and global market regulatory frameworks. Proven ability to influence executive stakeholders and communicate complex regulatory risks and opportunity at the leadership level. Experience with due diligence and regulatory integration for acquisitions or strategic partnerships. Gentherm is an Equal Opportunity Employer. We are committed to building an inclusive culture through Our Network of Engagement (ONE) where we value our differences and work together to positively impact the lives of our employees, customers, and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, genetic information, sexual orientation, gender identity, disability, or protected veteran status.

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