Global Regulatory Leader - Medical Devices & Ultrasound AI

Katalyst CRO; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Katalyst CRO is seeking an experienced Regulatory Affairs Leader to drive regulatory strategies, submissions, and ongoing compliance for medical devices across the USA, EU, and China. You will guide a team of regulatory professionals and collaborate with Clinical and Global Regulatory Affairs to support innovation and market access for ultrasound technologies.

You will develop global strategies for registrations, software updates (including AI features), and lifecycle management, ensuring timely

Qualifications

• Extensive knowledge of global medical device regulations and registration processes.
• Strong ability to present to all organizational levels and external partners.
• Ability to work with evolving technologies and global teams in a fast-paced setting.
• Familiarity with export control regulations: EAR/ITAR/OFAC.
• Experience leading regulatory submissions and lifecycle management.

Responsibilities

• Lead regulatory strategies for product approvals and compliance.
• Coordinate cross-functionally with Clinical and Global Regulatory Affairs teams.
• Develop and implement global regulatory strategies for new registrations and software updates.
• Oversee preparation and submission of technical documentation to FDA, EU authorities and others.
• Coach and supervise regulatory professionals toward strategic and operational goals.
• Interpret regulatory requirements for medical devices (IEC/ISO, FDA, MDR, NMPA).
• Define and execute submission timelines aligned with business goals.
• Liaise with regulatory authorities and internal/external stakeholders during reviews.
• Monitor regulatory changes internationally and communicate impacts to teams.
• Represent the company in industry groups and regulatory associations.
• Provide training on country-specific regulatory requirements.

Skills

Global regulatory expertise

FDA 510(k)

EU MDR knowledge

Presentation skills

Cross-functional leadership

Education

BS/MS degree or equivalent experience

Job description

Katalyst CRO is seeking an experienced Regulatory Affairs Leader to drive regulatory strategies, submissions, and ongoing compliance for medical devices across the USA, EU, and China. You will guide a team of regulatory professionals and collaborate with Clinical and Global Regulatory Affairs to support innovation and market access for ultrasound technologies.

You will develop global strategies for registrations, software updates (including AI features), and lifecycle management, ensuring timely