Global Director of Regulatory Affairs

Global Director Of Regulatory Affairs

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.

The Global Director Of Regulatory Affairs serves as the executive authority for regulatory strategy across Gentherm Medical, responsible for shaping and executing global market access pathways in alignment with business growth objectives. This role acts as a strategic advisor to the SVP/GM and executive leadership team, providing expert guidance on regulatory risk, competitive positioning, and market expansion opportunities. The Director will represent Gentherm Medical with regulatory authorities worldwide and ensure regulatory alignment is embedded into commercialization, portfolio planning, and long-term product lifecycle decisions.

Essential Functions And Responsibilities:

• Lead the development and execution of a multi-year global regulatory roadmap that enables new market entry, supports portfolio expansion, and drives speed-to-market competitiveness.
• Serve as the primary executive 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 executive 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 10 years of progressive regulatory affairs leadership experience in the medical device or pharmaceutical industry.
• Demonstrated success leading regulatory strategy for global market launches or major portfolio expansions.

Preferred Qualifications:

• RAC Certification or equivalent.
• Experience representing an organization during regulatory escalations or high-impact inspections at an executive level.
• Strong knowledge of U.S. FDA regulations, EU MDR, and global market regulatory frameworks.
• Proven ability to influence executive stakeholders and communicate complex regulatory risk and opportunity at the leadership level.
• Experience with due diligence and regulatory integration for acquisitions or strategic partnerships.

Travel: Domestic and international travel as needed to support global regulatory engagements.

Leadership Responsibilities:

• Manages the Regulatory Assurance team

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. Job Req ID: 9975 Country/Region: US