Senior Director Regulatory Affairs

Senior Director, Regulatory Affairs (fully on-site in San Diego)Submit your CV and any additional required information after you have read this description by clicking on the application button.SummaryOur client is a well-funded, growth-stage medical technology company developing a Class III active implantable platform at the intersection of healthcare and advanced engineering. This role serves as the senior regulatory leader for the company's San Diego operations, providing strategic and operational oversight across software, firmware, and hardware regulatory activities. The Senior Director will own regulatory strategy for new platform development, oversee ongoing product updates and manufacturing-related submissions, and work closely with engineering, quality, and clinical teams to ensure regulatory readiness throughout the product lifecycle.ResponsibilitiesLead regulatory strategy and submission planning for software, firmware, and hardware across new product development programs and product updatesAuthor and manage IDE, PMA, and PMA supplement submissions to the FDA; support additional international filings as neededDevelop and execute software and firmware regulatory strategy for complex implantable devices, including AI/ML considerations, change management, and lifecycle documentationProvide regulatory support for manufacturing-related activities, including process changes and design transfersPartner with engineering, software, quality, clinical, and operations teams to integrate regulatory requirements from early development through commercializationProvide regulatory guidance on new product concepts, design inputs, and technology xhyhwjd transfersSupport project planning and roadmaps with well-defined regulatory milestones and risk assessmentsMonitor evolving FDA regulations, guidance, and international standards relevant to Class III implantable devices and complex software/firmware-driven medical technologiesEnsure ongoing compliance with IDE and approved submission commitments, including reporting obligationsRepresent the company in FDA meetings, pre-submission interactions, and agency correspondenceMinimal travel expected (