Expertise with global medical device regulations, particularly USA 510(k) and EU MDR
Superior presentation and communication skills for diverse audiences
Proficiency in navigating evolving technologies and systems in a fast-paced environment
Familiarity with compliance regulations including EAR, ITAR, and OFAC sanctions
Responsibilities
Lead regulatory strategies and product submissions for timely approvals and compliance
Collaborate with Clinical and Global Regulatory Affairs to support innovation
Develop and execute global regulatory strategies for product registrations and updates
Prepare and submit technical documentation and regulatory dossiers to international authorities
Coach and oversee a team of regulatory professionals to meet strategic goals
Interpret and apply medical device regulatory requirements consistently
Act as a liaison with regulatory authorities and manage submission responses
Monitor regulatory changes and advise internal teams accordingly
Benefits
Opportunity to work with cutting-edge ultrasound technologies
Leadership role with significant impact on product compliance and market access
Collaborative cross-functional team environment
Support for professional development and knowledge-sharing
Participation in industry regulatory groups and associations
Full Job Description
Responsibilities:
In this critical role, you will 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
You will 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
Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.
