Role Overview for VP, Global Regulatory Submissions with a Medical Device Co. – Irvine, CA
JRG Partners is proud to partner with a pioneering, globally recognized medical device company in Irvine, California, in their search for a visionary Vice President of Global Regulatory Submissions. This is a paramount executive leadership position for an individual who is not only a master of the complex global regulatory landscape but also a strategic leader capable of guiding innovative, life-saving medical technologies from conception to market. As the VP, you will be the central pillar of the company’s global expansion and product sustainability, holding ultimate responsibility for developing and executing regulatory strategies that are both compliant and commercially astute. You will join a dynamic senior leadership team and be instrumental in shaping the company’s future, ensuring that its groundbreaking products reach patients and healthcare providers worldwide in a timely and efficient manner.
This role demands a unique blend of technical regulatory expertise, strategic foresight, and inspirational leadership. You will be tasked with building, mentoring, and leading a high-performing global regulatory affairs team, fostering a culture of excellence, collaboration, and proactive problem-solving. Your influence will extend across the entire organization, as you collaborate closely with R&D, Clinical Affairs, Quality Assurance, and Commercial teams to integrate regulatory requirements seamlessly into the product lifecycle. The ideal candidate will be a strategic thinker who can anticipate regulatory trends, navigate challenges with agility, and communicate complex information with clarity and conviction to both internal stakeholders and external regulatory bodies. This is a career-defining opportunity to make a tangible impact on global health outcomes by ensuring the compliant and successful launch of next-generation medical devices.
Key Responsibilities of VP, Global Regulatory Submissions with a Medical Device Co. – Irvine, CA
Strategic Leadership & Vision
Develop, articulate, and execute a comprehensive global regulatory strategy that aligns with the company’s long-term business objectives. Provide strategic regulatory guidance to the executive team and project teams for new product development, product modifications, and geographic expansion.
Global Submission Management
Direct and oversee the planning, preparation, and submission of all regulatory applications and registrations to global health authorities. This includes, but is not limited to, Premarket Approvals (PMAs), 510(k) Premarket Notifications, De Novo requests, Investigational Device Exemptions (IDEs), CE Markings under EU MDR, and other international dossiers for markets in Asia-Pacific, Latin America, and Canada.
Health Authority Engagement
Serve as the primary senior-level contact for regulatory agencies worldwide, including the FDA, Notified Bodies, and other international authorities. Lead and strategize for key meetings, negotiations, and responses to agency inquiries to ensure positive and timely outcomes.
Team Development & Mentorship
Lead, manage, and develop a world-class global regulatory affairs organization. Provide coaching, mentorship, and professional development opportunities to team members, empowering them to achieve their full potential and drive departmental success. Foster a collaborative and compliant-focused culture.
Regulatory Intelligence & Compliance
Establish and maintain a robust regulatory intelligence process to monitor, interpret, and communicate changes in the global regulatory environment. Ensure that the company’s policies, procedures, and product development processes are in full compliance with all applicable regulations, including a comprehensive understanding of FDA regulations for medical devices, ISO 13485, EU MDR/IVDR, and other relevant international standards.
Cross-Functional Collaboration
Act as a key strategic partner to R&D, Clinical, Quality, Operations, and Marketing departments. Provide critical regulatory input throughout the entire product lifecycle, from initial design and development to post-market surveillance, ensuring regulatory requirements are met at every stage.
Due Diligence & Business Development
Provide expert regulatory assessment and guidance for potential mergers, acquisitions, and licensing deals. Evaluate the regulatory viability and risk profile of new technologies and business opportunities to support informed strategic decision-making.
Budget & Resource Management
Develop and manage the departmental budget, ensuring optimal allocation of financial and human resources to meet strategic objectives and submission timelines. Drive efficiency and implement best practices within the regulatory function.
Post-Market Surveillance
Oversee the regulatory aspects of post-market activities, including the review and submission of vigilance reports, adverse event reporting, and management of product recalls or field actions, ensuring timely and compliant communication with all relevant authorities.
Requirements for the VP, Global Regulatory Submissions with a Medical Device Co. – Irvine, CA
Educational Background
A minimum of a Bachelor’s degree in a relevant scientific, engineering, or life sciences discipline is required. An advanced degree (MS, PhD, JD, or MBA) is highly preferred.
Executive Experience
A minimum of 15 years of progressive experience within the medical device industry’s regulatory affairs function, with at least 7-10 years in a significant leadership capacity managing teams and global strategies.
Extensive Submission Experience
Proven track record of successful submissions and approvals for a variety of complex medical devices (Class II and Class III) in major global markets. Deep, hands-on experience with FDA submissions (PMA, 510(k), IDE) and EU submissions under MDD/MDR (CE Marking, Technical Files/Design Dossiers) is essential.
Global Regulatory Acumen
Demonstrated expertise in navigating the regulatory landscapes of key international markets beyond the US and EU, such as China (NMPA), Japan (PMDA), Canada (Health Canada), and Brazil (ANVISA).
Leadership & Communication Skills
Exceptional leadership presence with the proven ability to inspire, motivate, and manage a diverse, global team. Must possess superior written and verbal communication skills, with the ability to effectively articulate complex regulatory concepts to a wide range of audiences, from engineers to board members.
Strategic & Analytical Thinking
Strong strategic planning and critical thinking skills, with the ability to analyze the regulatory risks and benefits of business decisions and develop innovative, effective solutions to complex regulatory challenges.
Interpersonal & Negotiation Skills
A history of building strong, collaborative relationships with regulatory agency personnel. Must be a skilled negotiator with the ability to influence and achieve consensus among diverse stakeholders.
Certifications
Regulatory Affairs Certification (RAC) is highly desirable and considered a significant asset.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier talent by offering a highly competitive and comprehensive compensation and benefits package. As a key member of the executive team, you can expect:
Executive Compensation
A highly competitive base salary complemented by a substantial annual performance-based bonus and long-term incentive plan (equity/stock options).
Comprehensive Health & Wellness
Premier medical, dental, and vision insurance plans for you and your dependents, along with robust wellness programs and resources.
Retirement Planning
A generous 401(k) retirement savings plan with a significant company match to help you secure your financial future.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and numerous paid company holidays, to support a healthy work-life integration.
Professional Growth
Ample opportunities for professional development, including support for attending industry conferences, workshops, and pursuing further education and certifications.
Relocation Support
A comprehensive relocation assistance package is available for qualified candidates moving to the vibrant Irvine, CA area.
Innovative Culture
The opportunity to work in a state-of-the-art facility with a brilliant, passionate team dedicated to making a difference in the world of healthcare.
How to Apply
This is a confidential search conducted by JRG Partners. If you are a visionary regulatory leader ready to take on a new challenge and drive the success of a leading medical device innovator, we encourage you to apply. To be considered for this executive opportunity, please submit your resume and a cover letter outlining your qualifications and strategic accomplishments through our secure portal.
