Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR
Superior presentation skills for effective communication
Ability to work with evolving technologies in a fast-paced environment
Knowledge of export control laws and regulations including EAR, ITAR, and OFAC sanctions.
Responsibilities
Lead regulatory strategies and team to ensure timely product approvals
Collaborate cross-functionally to support innovation and market access
Develop global regulatory strategies for new products and software updates
Prepare and submit technical documentation to regulatory authorities
Coaching the regulatory team to meet strategic and operational goals
Interpret and apply regulatory requirements for medical devices
Act as a liaison with regulatory authorities and stakeholders
Monitor changes in international regulations and communicate impacts
Represent the company in industry groups and regulatory associations
Benefits
Opportunity to work with cutting-edge ultrasound technologies
Collaborative environment with cross-functional teams
Leadership role overseeing a team of regulatory professionals
Access to ongoing training and knowledge-sharing initiatives
Active participation in industry 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
ct 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
bility 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.
