Role Overview for VP Quality & Regulatory Affairs, Biomedical Technology – San Diego, CA
JRG Partners is proud to partner with a pioneering biomedical technology company at the forefront of medical innovation. Located in the vibrant life sciences hub of San Diego, CA, our client is dedicated to developing groundbreaking medical devices that significantly improve patient outcomes. We are seeking a visionary and strategic leader to join their executive team as the Vice President of Quality & Regulatory Affairs. This is a paramount role responsible for crafting and executing the global quality and regulatory strategy, ensuring the company’s products meet the highest standards of safety, efficacy, and compliance across all target markets.
The VP of Quality & Regulatory Affairs will be the principal architect of the company’s compliance framework, providing executive leadership and hands-on guidance for all related functions. This individual will serve as the primary liaison with regulatory bodies such as the FDA, Notified Bodies, and other international health authorities. You will be instrumental in navigating the complex and evolving global regulatory landscape, from initial product conception and clinical trials to commercialization and post-market surveillance. This role demands a leader who can seamlessly blend deep technical expertise with strategic business acumen, fostering a robust culture of quality that permeates every facet of the organization. You will be responsible for building, mentoring, and leading a high-performing team, ensuring that all quality and regulatory objectives are met in alignment with the company’s ambitious growth plans. Your leadership will directly impact the company’s ability to bring life-changing technologies to patients worldwide, making this a truly impactful and rewarding opportunity.
Key Responsibilities of VP Quality & Regulatory Affairs, Biomedical Technology – San Diego, CA
Strategic Leadership & Vision
- Develop, implement, and champion the company’s global quality and regulatory affairs strategy in alignment with corporate goals and commercial objectives.
- Serve as a key member of the senior leadership team, providing critical input on business strategy, product development pipelines, and risk management from a quality and regulatory perspective.
- Establish and monitor key performance indicators (KPIs) for the Quality and Regulatory departments to drive continuous improvement and operational excellence.
- Anticipate and interpret changes in the global regulatory environment, advising the executive team on potential impacts and formulating proactive strategies to address them.
- Cultivate a world-class culture of quality and compliance throughout the organization, promoting accountability and a shared commitment to patient safety.
Regulatory Affairs & Global Submissions
- Direct all regulatory submission activities for new products and product modifications, including 510(k)s, PMAs, De Novo petitions, and international registrations (e.g., EU MDR/IVDR for CE Marking, Health Canada).
- Serve as the primary correspondent with regulatory agencies, leading negotiations and discussions to ensure timely and successful product approvals.
- Oversee the development and maintenance of all regulatory documentation, including technical files, design dossiers, and essential requirements checklists.
- Provide regulatory guidance to R&D, Clinical, and Marketing teams throughout the entire product lifecycle to ensure all development activities are compliant with global standards.
- Manage post-market regulatory activities, including adverse event reporting (MDRs), recalls, and field safety corrective actions, ensuring full compliance with all reporting requirements.
Quality Management System (QMS) Oversight
- Provide executive oversight for the company’s Quality Management System (QMS) to ensure its effectiveness and compliance with relevant standards, including ISO 13485 and the FDA’s Quality System Regulation (QSR) 21 CFR Part 820.
- Lead the management review process, presenting QMS performance data to the executive team and driving strategic decisions for system improvements.
- Direct all aspects of the QMS, including but not limited to CAPA (Corrective and Preventive Action), document control, design controls, supplier quality management, internal auditing, and production/process controls.
- Ensure the QMS is appropriately scaled to support the company’s growth, from early-stage development to full-scale commercial manufacturing.
- Champion the use of quality data and statistical methods to identify trends, drive root cause analysis, and implement effective, data-driven improvements across the organization.
Compliance, Audits, and Risk Management
- Host and manage all external audits and inspections from regulatory authorities (e.g., FDA, Notified Bodies) and strategic partners, ensuring successful outcomes.
- Oversee the internal audit program to proactively identify compliance gaps and ensure the ongoing health of the QMS.
- Lead the development and implementation of a comprehensive, risk-based approach to quality and compliance, integrating risk management principles (ISO 14971) into all aspects of the product lifecycle.
- Ensure all company training programs related to quality and regulatory compliance are effective and maintained.
Requirements for the VP Quality & Regulatory Affairs, Biomedical Technology – San Diego, CA
Required Qualifications
- Bachelor’s degree in a scientific, engineering, or related technical field is required. An advanced degree (MS, PhD, or MBA) is highly preferred.
- A minimum of 15 years of progressive experience in Quality and Regulatory Affairs within the medical device or biomedical technology industry.
- At least 7 years of experience in a senior leadership role (Director level or above), with a proven track record of building and managing high-performing teams.
- Demonstrated, in-depth expertise in FDA regulations (21 CFR 820, 803, 806), ISO 13485, and global regulatory requirements, including EU MDR/IVDR.
- Extensive hands-on experience in preparing and managing successful regulatory submissions for Class II and/or Class III medical devices in the US and international markets.
- Proven experience successfully hosting and managing FDA inspections and Notified Body audits.
Preferred Qualifications
- Experience with devices incorporating software (SaMD), electrical components, or novel biomaterials.
- Regulatory Affairs Certification (RAC) is a significant plus.
- Experience in a fast-paced, high-growth start-up or scale-up environment.
- Strong experience with electronic Quality Management Systems (eQMS).
- Experience managing both quality assurance and regulatory affairs functions for a commercial-stage company.
Leadership Competencies & Personal Attributes
- Exceptional leadership and communication skills, with the ability to inspire, influence, and motivate across all levels of the organization.
- Strong strategic thinking and problem-solving abilities, capable of navigating ambiguity and making sound decisions under pressure.
- Highly collaborative team player with a proven ability to work effectively with cross-functional partners in R&D, Clinical, Operations, and Commercial teams.
- Impeccable ethical standards, integrity, and a deep commitment to quality and patient safety.
- Detail-oriented with excellent organizational and project management skills.
Benefits & Perks Offered
Our client is committed to investing in their employees and offers a highly competitive and comprehensive benefits package, including:
- Competitive base salary and executive-level annual bonus program.
- Significant equity/stock option package, providing a meaningful stake in the company’s success.
- Comprehensive health, dental, and vision insurance plans with low employee contributions.
- Generous 401(k) plan with a strong company match.
- Unlimited Paid Time Off (PTO) policy to support work-life balance.
- Substantial budget for professional development, including conferences, certifications, and continued education.
- State-of-the-art office and lab facilities in the heart of San Diego’s biotech community.
- Company-sponsored wellness programs and a stipend for health and fitness activities.
- Relocation assistance available for exceptional candidates.
How to Apply
This is a retained search managed exclusively by JRG Partners. If you are a transformative Quality and Regulatory leader passionate about driving innovation in the biomedical field, we encourage you to apply. To be considered for this pivotal role, please submit your resume and a cover letter detailing your qualifications and leadership philosophy. Qualified candidates will be contacted directly by a representative from JRG Partners’ best biomedical executive recruiters team. We look forward to learning more about how your expertise can help shape the future of our client’s groundbreaking technology.
