Director of Regulatory Affairs

Director, Regulatory AffairsShape the Future of DiagnosticsAbout the RoleWe’re looking for a strategic and hands-on Director of Regulatory Affairs to lead our global regulatory programs for innovative in vitro diagnostics (IVDs), lab instruments, and reagents. In this high-impact role, you’ll be the organization’s regulatory expert and trusted partner — driving product development from concept through commercialization while ensuring compliance and accelerating market success.You’ll collaborate across R&D, Clinical, Quality, and Marketing to turn complex regulatory requirements into clear, actionable strategies that enable innovation. If you’re a seasoned regulatory leader who thrives on solving challenges and guiding teams toward global approvals, this is your opportunity to make a lasting mark.What You’ll DoLead with VisionDefine and execute global regulatory strategies that support every stage of the product lifecycle — from early design through post-market success.Partner closely with cross-functional teams to align regulatory goals with business priorities.Stay ahead of evolving FDA, IVDR, and international frameworks, and translate insights into proactive strategies.Drive Global ApprovalsOversee high-quality submissions such as 510(k), PMA, Technical Files, and Health Canada applications.Build strong relationships with regulatory authorities (FDA, Notified Bodies, etc.) and lead communications throughout the review process.Champion Compliance & Risk ManagementEnsure ongoing compliance with FDA QSR, ISO 13485, IVDR, and other global standards.Guide teams through audits, inspections, and product change processes with confidence and clarity.Inspire & Develop TeamsLead and mentor a skilled regulatory team, fostering growth, collaboration, and a continuous improvement mindset.Create an environment where people feel empowered to innovate while maintaining the highest standards of integrity.What You BringBachelor’s degree in life sciences, engineering, or related field (advanced degree preferred).10+ years of regulatory affairs experience in IVDs or medical devices, with 5+ years in a leadership role.Proven track record with U.S. FDA and international regulatory submissions.Deep knowledge of global regulatory frameworks (21 CFR Part 820, ISO 13485, IVDR).Exceptional communication, leadership, and project management skills.Why Join UsYou’ll be part of a purpose-driven team developing technologies that impact lives around the world. This is a chance to lead with influence, drive innovation, and help bring diagnostic breakthroughs to market — all in a culture that values collaboration, curiosity, and professional growth.