Role Overview for SVP, Quality & Compliance with a Medical Device Co. – Irvine, CA
JRG Partners is proud to represent a pioneering medical device company based in the innovation hub of Irvine, California. Our client is a global leader in developing and manufacturing life-changing medical technologies that address complex healthcare challenges. With a commitment to excellence and a patient-first philosophy, they are seeking a visionary and strategic Senior Vice President (SVP) of Quality & Compliance to join their executive leadership team.
This is a paramount role responsible for the global leadership, strategic direction, and operational execution of the company’s quality assurance and regulatory compliance functions. Reporting directly to the Chief Executive Officer, the SVP will be the ultimate authority on quality, ensuring that all products, processes, and systems not only meet but exceed the stringent requirements of worldwide regulatory bodies.
The ideal candidate will be a seasoned executive with an impeccable track record in the medical device industry, capable of fostering a robust culture of quality that permeates every facet of the organization. You will be instrumental in safeguarding patient safety, maintaining the company’s sterling reputation, and enabling its continued growth and success on a global scale. This position requires a leader who can balance strategic foresight with hands-on tactical execution, driving continuous improvement and innovation within the quality and compliance landscape.
Key Responsibilities of SVP, Quality & Compliance with a Medical Device Co. – Irvine, CA
The SVP of Quality & Compliance will have a broad and impactful scope of responsibilities, including but not limited to:
Strategic Leadership & Vision
- Develop, articulate, and execute a comprehensive global quality and compliance strategy that aligns with the company’s overall business objectives and long-range plans.
- Serve as a key member of the executive leadership team, providing expert counsel on all quality-related matters and contributing to corporate strategy and decision-making.
- Champion a proactive, world-class culture of quality and continuous improvement throughout the entire organization, from R&D to post-market surveillance.
- Establish and monitor key performance indicators (KPIs) and metrics to drive performance, assess the health of the quality system, and report progress to the executive team and Board of Directors.
- Anticipate changes in the global regulatory landscape and proactively adapt the company’s quality systems and strategies to maintain compliance and competitive advantage.
Quality Management System (QMS) Oversight
- Provide ultimate oversight for the development, implementation, and maintenance of a robust and efficient global Quality Management System (QMS) compliant with all applicable regulations.
- Ensure the QMS adheres to standards such as ISO 13485, FDA Quality System Regulation (QSR), EU Medical Device Regulation (MDR), and other international requirements.
- Direct all aspects of the QMS, including but not limited to Design Controls, Risk Management (ISO 14971), CAPA (Corrective and Preventive Action), Complaint Handling, Production and Process Controls (P&PC), and Supplier Quality Management.
- Lead Management Review meetings to ensure the ongoing suitability, adequacy, and effectiveness of the QMS.
- Drive initiatives to streamline and digitize quality processes, leveraging technology to enhance efficiency, data integrity, and compliance.
Regulatory Compliance & Agency Interaction
- Serve as the primary point of contact and official correspondent with global regulatory agencies, including the FDA, Notified Bodies, and other international health authorities.
- Lead the organization through all regulatory inspections and audits, ensuring successful outcomes and timely, effective responses to any observations.
- Oversee the regulatory submissions process for new products and product changes, collaborating closely with the Regulatory Affairs department.
- Ensure all post-market activities, including vigilance reporting, recalls, and field actions, are managed effectively and in full compliance with global regulations.
Team Leadership & Development
- Build, lead, and mentor a high-performing, multi-disciplinary global quality and compliance organization.
- Foster a collaborative and empowering environment that attracts, retains, and develops top-tier talent.
- Establish clear goals, provide regular feedback, and manage the performance and professional development of the entire quality team.
- Manage the departmental budget, ensuring optimal allocation of resources to meet strategic objectives.
Requirements for the SVP, Quality & Compliance with a Medical Device Co. – Irvine, CA
We are seeking a distinguished leader with a profound understanding of the medical device quality and regulatory environment. The successful candidate will possess:
Education & Experience
- A minimum of a Bachelor of Science (B.S.) degree in Engineering, Life Sciences, or a related technical field. An advanced degree (M.S., M.B.A., Ph.D.) is strongly preferred.
- A minimum of 20 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
- At least 10 years of experience in a senior leadership capacity (e.g., Vice President, Senior Director) with responsibility for a global quality organization.
- Demonstrated experience with a wide range of medical devices, including Class II and Class III devices. Experience with software as a medical device (SaMD) and combination products is highly desirable.
- A proven track record of successfully leading companies through FDA inspections, Notified Body audits, and other significant regulatory assessments.
Knowledge & Skills
- Expert-level knowledge of global medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, EU MDR 2017/745, and risk management standard ISO 14971.
- Exceptional strategic thinking and problem-solving abilities, with a demonstrated capacity to develop and execute complex, long-term plans.
- Outstanding leadership and interpersonal skills, with the ability to influence and build consensus across all levels of a global organization.
- Excellent written and verbal communication skills, capable of effectively presenting complex information to executives, regulatory bodies, and technical teams.
- Strong business and financial acumen, with experience managing significant departmental budgets.
- Professional certifications such as ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or RAPS Regulatory Affairs Certification (RAC) are a significant plus.
Benefits & Perks Offered
Our client offers a highly competitive and comprehensive executive compensation and benefits package, designed to attract and retain the very best talent. This includes:
Competitive Compensation
A highly attractive base salary, annual performance-based bonus, and a significant long-term incentive package (stock options/RSUs).
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance for you and your dependents, along with company-sponsored wellness programs.
Retirement Planning
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.
Relocation Assistance
A comprehensive relocation package is available for the ideal candidate.
Professional Growth
Ample opportunities for continued professional development, including executive coaching and attendance at industry-leading conferences.
How to Apply
If you are a visionary quality leader ready to make a significant impact at a world-class medical device company, we encourage you to apply for this exceptional opportunity. JRG Partners is managing this exclusive search. To be considered, please submit your resume and a cover letter detailing your qualifications and strategic vision for this role.
JRG Partners is a leader in executive search, specializing in connecting top-tier talent with innovative companies. To learn more about our expertise in this sector, please visit the JRG Partners’ Life Sciences and Healthcare practice page. We are committed to fostering a diverse and inclusive workplace and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
