Regulatory Affairs Manager

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

• 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

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.