The client is seeking a Director of Regulatory Affairs for Medical Devices to lead global regulatory strategy and labeling across a diverse medical device product portfolio. This highly visible leadership role will guide regulatory direction at an executive level, supporting innovation from early development through commercialization and extending into post-market compliance and lifecycle management. The role will provide executive-level guidance for new product introductions and existing commercial portfolios, ensuring alignment with evolving regulatory requirements.
Key responsibilities include defining and executing global regulatory strategy aligned to business objectives, overseeing global labeling strategy, and serving as the primary liaison to regulatory authorities worldwide. The director will manage major regulatory submissions and technical documentation, including device pathways such as 510(k), PMA, and IDE, as well as CE Mark-related documentation and other applicable pharmaceutical filings where relevant. The role will champion compliance programs involving areas such as UDI and state licensing, anticipate regulatory risks, and develop mitigation strategies while guiding cross-functional teams across R&D, Clinical, Quality, Legal, Manufacturing, and Commercial.
The ideal background includes progressive regulatory affairs experience in medical devices, with demonstrated success leading global submissions and securing approvals for complex technologies, including direct interaction with regulatory agencies in the U.S. and internationally. Strong experience with global labeling oversight and regulatory compliance across multiple international markets is expected, along with people leadership experience managing senior professionals. Preferred qualifications may include experience with sterile disposables and/or electro-mechanical devices with embedded software, exposure to drug/device combination products, collaboration with clinical teams during trial phases, and partnership with quality management systems; additional regulatory certification is a plus. The director will be expected to translate complex regulations into practical business solutions, influence senior stakeholders, and build a culture of regulatory excellence.