Role Overview for VP, Regulatory Affairs with a Diagnostics Manufacturer – Irvine, CA
JRG Partners is proud to partner with a pioneering diagnostics manufacturer at the forefront of medical innovation. Located in the vibrant biotech hub of Irvine, California, our client is dedicated to developing and commercializing groundbreaking diagnostic solutions that improve patient outcomes and transform healthcare. We are seeking a visionary and strategic Vice President of Regulatory Affairs to join their executive leadership team. This is a pivotal role responsible for architecting and executing the global regulatory strategy that will guide the company’s products from development to market and beyond.
The VP of Regulatory Affairs will be a hands-on leader, providing expert guidance and direction to a talented team of regulatory professionals. This individual will serve as the primary interface with global regulatory agencies, including the FDA, Notified Bodies, and other international health authorities. The ideal candidate is a seasoned expert in the in-vitro diagnostics (IVD) and medical device space, with a proven track record of successful product submissions and a deep understanding of the complex and evolving regulatory landscape.
You will be instrumental in shaping the company’s regulatory culture, ensuring unwavering compliance while enabling rapid innovation. This position requires a strategic thinker with exceptional leadership skills, the ability to navigate complex regulatory challenges, and a passion for bringing life-changing technologies to patients worldwide. You will be a key advisor to the executive team, providing critical insights on regulatory risks, opportunities, and trends that will directly impact the company’s long-term success and strategic direction.
Key Responsibilities of VP, Regulatory Affairs with a Diagnostics Manufacturer – Irvine, CA
Global Regulatory Strategy Development
Architect, implement, and lead the comprehensive global regulatory strategy for all new and existing products. This includes defining regulatory pathways, timelines, and resource requirements for key markets such as the US, EU, Canada, and Asia-Pacific. You will ensure that the regulatory strategy is fully aligned with the company’s commercial objectives and product development lifecycle.
Leadership and Team Mentorship
Lead, manage, and mentor a high-performing regulatory affairs department. Foster a culture of excellence, collaboration, accountability, and continuous improvement. You will be responsible for professional development, performance management, and organizational scaling to support a growing product portfolio.
Regulatory Submissions and Approvals
Oversee the entire lifecycle of regulatory submissions, ensuring they are of the highest quality, scientifically sound, and submitted on schedule. This includes direct oversight of the preparation and filing of 510(k)s, De Novo requests, Premarket Approvals (PMAs), and Investigational Device Exemptions (IDEs) with the FDA, as well as Technical Files for CE Marking under the In Vitro Diagnostic Regulation (IVDR) in Europe.
Health Authority Interactions
Serve as the principal point of contact with all regulatory agencies. Cultivate and maintain strong, positive relationships with officials at the FDA, Notified Bodies, and other international health authorities. You will lead all negotiations, meetings, and formal communications related to submissions, inspections, and compliance matters.
Regulatory Compliance and Quality Systems
Ensure robust compliance with all applicable domestic and international regulations and standards. This includes FDA’s Quality System Regulation (21 CFR 820), ISO 13485, and other relevant requirements. You will collaborate closely with the Quality Assurance team to maintain a state of inspection-readiness and drive continuous improvement in the quality management system.
Cross-Functional Collaboration
Act as a key strategic partner to internal stakeholders across the organization. Provide expert regulatory guidance to R&D, Clinical Affairs, Operations, and Commercial teams throughout the product lifecycle, from initial concept and design control to post-market activities, ensuring regulatory requirements are integrated seamlessly.
Regulatory Intelligence
Proactively monitor the global regulatory environment for changes in regulations, standards, and guidance documents. Analyze the potential impact of these changes on the company’s products and business strategy, and develop proactive plans to adapt and ensure continued compliance and market access.
Post-Market Surveillance
Oversee all post-market regulatory activities, including the management of adverse event reporting (MDRs/Vigilance), product recalls or field actions, and the development of post-market surveillance plans and reports as required by global regulations.
Budget and Resource Management
Develop and manage the annual budget for the Regulatory Affairs department. Ensure the efficient allocation of financial and human resources to meet strategic goals and departmental objectives.
Requirements for the VP, Regulatory Affairs with a Diagnostics Manufacturer – Irvine, CA
Educational Background
A Bachelor’s degree in a scientific, engineering, or related field is required. An advanced degree (MS, PhD, MD, or PharmD) is highly preferred.
Professional Experience
A minimum of 15 years of progressive experience in regulatory affairs within the medical device or in-vitro diagnostics (IVD) industry. At least 8 years of experience in a leadership capacity, managing and developing regulatory teams.
Submission Expertise
Demonstrated, hands-on experience and a successful track record with a variety of regulatory submissions, including 510(k), PMA, De Novo, and IDEs. Extensive experience with EU regulations, including a deep and practical understanding of the transition from IVDD to IVDR, is essential.
Regulatory Knowledge
Expert-level knowledge of US FDA regulations (e.g., 21 CFR Parts 803, 806, 820), EU IVDR/MDR, ISO 13485, and other international regulatory requirements (e.g., Health Canada, TGA, NMPA).
Leadership Skills
Proven ability to lead, influence, and build consensus across all levels of an organization. A strategic thinker with the ability to translate complex regulatory requirements into actionable business plans.
Communication Skills
Exceptional written and verbal communication skills. Must be able to effectively communicate complex regulatory concepts to diverse audiences, including executive leadership, technical teams, and regulatory authorities.
Certifications
Regulatory Affairs Certification (RAC) is highly desirable.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a comprehensive and competitive benefits package, including:
Competitive Compensation
A highly competitive base salary, annual performance-based bonus, and a significant equity/stock option package.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your dependents.
Retirement Savings
A robust 401(k) plan with a generous company match to help you plan for your future.
Work-Life Balance
A generous Paid Time Off (PTO) policy, paid holidays, and flexible work arrangements.
Professional Growth
A strong commitment to employee development, with opportunities for continued education, conference attendance, and career advancement.
Relocation Assistance
A comprehensive relocation package is available for exceptional candidates.
Wellness Programs
Company-sponsored wellness initiatives and resources to support your physical and mental well-being.
How to Apply
If you are a strategic regulatory leader ready to make a significant impact in the diagnostics industry, we encourage you to apply. This is a unique opportunity to join a dynamic executive team and shape the future of a rapidly growing company. To be considered for this confidential search, please submit your resume and a cover letter. For more information about our expertise in this space, please visit the JRG Partners’ Medical Device & Diagnostics practice page. We look forward to connecting with you.
