Overview In this role you drive global regulatory strategies and submissions for medical devices, including AI-enabled software and ultrasound technologies. You will lead a regulatory team, partner with Clinical and Global Regulatory Affairs, and ensure timely approvals across USA, EU, China, and other markets. You’ll interpret requirements, manage dossiers, and liaise with authorities to support market access and ongoing compliance. This position offers the chance to shape regulatory programs, influence cross-functional decisions, and advance innovative medical devices at scale.

ResponsibilitiesLead global regulatory strategies for new registrations, software updates, and product lifecycle management across key markets (FDA, EU MDR, NMPA)Oversee preparation and submission of technical documentation and regulatory dossiers to authorities (FDA, NMPA, EU bodies)Coach and manage a team of regulatory professionals to meet strategic and operational goalsInterpret regulatory requirements for medical devices (IEC/ISO, NMPA, FDA 510(k), MDR) and define submission plansAct as liaison to regulatory authorities and stakeholders; manage review interactions and responsesMonitor international regulatory changes and communicate impacts to cross-functional teamsRepresent the company in industry groups or regulatory associationsSupport training and knowledge-sharing on country-specific regulatory requirements Key requirementsBS/MS degree or equivalent experienceExpertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDRSuperior presentation and communication skills with all levels of the organizationAbility to work with evolving technologies, systems, and global teams in a fast-paced environmentKnowledge of EAR, ITAR, and OFAC sanctions regulationsstrong communicationcross-functional collaborationleadershipglobal medical device regulatory expertise (FDA 510(k), EU MDR, NMPA)technical documentation and regulatory dossierssubmissions management

Experience: 5 years required