Regulatory Affairs Manager

Responsibilities

• Lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more
• Work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions
• Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management
• Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies
• Oversee and coach a team of regulatory professionals to support both strategic and operational objectives
• Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.)
• Define and execute submission strategies to meet timelines and business goals
• Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review
• Monitor changes in international regulatory environments and communicate impacts to internal teams
• Represent the company in industry groups or regulatory associations, where appropriate
• Support training and knowledge-sharing on country-specific regulatory requirements within the organization

Requirements

• BS/MS degree or equivalent experience required
• Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR
• Superior presentation skills when communicating with all levels of the organization, business partners, and external sources
• Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment