Global Director of Regulatory Affairs

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.

• 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.

• 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.

• 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.

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

Manages the Regulatory Assurance team