Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR
Superior presentation skills for effective communication across various levels
Ability to navigate evolving technologies in a fast-paced, matrixed environment
Familiarity with export regulations including EAR, ITAR, and OFAC sanctions
Responsibilities
Lead regulatory strategies and product submissions to ensure timely approvals and compliance
Collaborate cross-functionally to support innovation and market access for ultrasound technologies
Develop global regulatory strategies for new products and software updates including AI features
Prepare and submit technical documentation to authorities like NMPA, FDA, and EU notified bodies
Oversee, coach, and support a team of regulatory professionals
Interpret and apply complex regulatory requirements for medical devices
Act as a liaison to regulatory authorities and manage interactions during submission reviews
Monitor global regulatory changes and communicate impacts internally
Represent the company in industry or regulatory groups as needed
Facilitate training on regulatory requirements across different countries
Benefits
Comprehensive training and development opportunities
Supportive team culture encouraging innovation and collaboration
Opportunities to represent the company in industry-level discussions and regulatory groups
Access to cutting-edge technologies and continuous learning in the field of ultrasound solutions
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.
