Overview In this pivotal role you lead regulatory strategies and submissions for ultrasound technologies, coordinating a global team to achieve timely approvals and ongoing compliance. You collaborate across Clinical and Global Regulatory Affairs to expand market access in USA, EU, China, and beyond, including AI-enabled software updates. You will shape regulatory pathways, coach staff, and manage interactions with authorities to support innovation and lifecycle management. This role offers meaningful impact by aligning regulatory strategy with business goals and cross-functional delivery.
Responsibilities- Develop global regulatory strategies for new products and software updates
- Lead preparation and submission of regulatory dossiers to authorities (FDA, EU, NMPA)
- Oversee and mentor a regulatory team to support strategic and operational goals
- Interpret regulatory requirements (IEC/ISO, NMPA, FDA 510(k), MDR) and define submission timelines
- Act as liaison to regulatory authorities and stakeholders; manage submission reviews
- Monitor international regulatory changes and communicate impact to internal teams
- Represent the company in industry groups/regulatory associations
- Support training on country-specific regulatory requirements within the organization
Key requirements- BS/MS degree or equivalent experience
- Expertise with global medical device regulations, especially USA 510(k) and EU MDR
- Superior presentation skills for internal and external audiences
- Ability to operate in a fast-paced, matrixed, global environment
- Knowledge of EAR/ITAR/OFAC sanctions regulations
- strong leadership
- cross-functional collaboration
- clear communication
- global medical device regulatory knowledge (FDA 510(k), EU MDR)
- regulatory dossier preparation
- regulatory strategy development
