Vice President, Regulatory Affairs
Position Overview
The Vice President, Regulatory Affairs will provide strategic and operational leadership for the Regulatory Affairs function supporting a global medical device and diagnostics business. This executive will be responsible for developing and executing regulatory strategies that support product innovation, commercialization, lifecycle management, and continued business growth.
Working closely with senior business leadership and cross-functional partners across R&D, Quality, Clinical/Medical Affairs, Marketing, Legal, and Operations, the Vice President will ensure regulatory considerations are integrated into both product development and broader business strategy.
This leader will serve as a senior regulatory authority within the organization, providing guidance on complex regulatory matters, interacting directly with FDA and other global regulatory agencies, and ensuring the organization is positioned to successfully navigate an evolving regulatory environment.
The position requires an accomplished Regulatory Affairs executive with significant medical device and diagnostics experience, strong global regulatory expertise, and a demonstrated ability to lead and develop high-performing teams. These themes closely reflect the leadership scope of the source position while intentionally broadening the language beyond the original Specimen Management framing.
Key Responsibilities
- Develop and lead global regulatory strategies that support business objectives, new product development, product launches, and lifecycle management.
- Serve as a strategic regulatory partner to senior business leadership, helping evaluate opportunities, establish priorities, assess regulatory risk, and determine appropriate paths forward.
- Provide executive-level oversight of global premarket regulatory activities and submissions.
- Represent the organization in interactions with FDA and other regulatory authorities, including meetings, negotiations, submissions, and responses to complex regulatory matters.
- Establish regulatory strategies for medical devices and diagnostic products across the United States and international markets.
- Partner closely with R&D, Quality, Clinical/Medical Affairs, Marketing, Operations, and other functions to ensure regulatory requirements are incorporated throughout product development and commercialization.
- Provide leadership and strategic direction for regulatory submissions, including 510(k)s, IDEs, EU Technical Documentation/Files, and other global registrations.
- Partner with Clinical and Medical Affairs on clinical strategies and programs supporting regulatory submissions and product approvals.
- Build productive relationships with regulatory agencies, industry organizations, and other external stakeholders.
- Lead, mentor, and develop Regulatory Affairs professionals while building organizational capability and succession plans.
Education & Experience
- Bachelor's degree in biology, chemistry, engineering, life sciences, or another relevant technical discipline required.
- Advanced degree such as an MS, MBA, PhD, or other relevant graduate degree preferred.
- Regulatory Affairs Certification (RAC) is a plus.
- 15+ years of progressively responsible Regulatory Affairs experience within the medical device, diagnostics, or related healthcare industry.
- Extensive experience developing and executing global regulatory strategies for medical devices and/or in vitro diagnostic products.
- Demonstrated success obtaining regulatory clearances and approvals in the United States and international markets.
Leadership Competencies
- Strong business acumen with the ability to balance regulatory requirements, patient needs, risk, innovation, and commercial objectives.
- Executive presence and credibility when interacting with senior leadership, regulatory agencies, and external stakeholders.
- Ability to make sound decisions in situations involving ambiguity, changing requirements, or incomplete information.
- Strong communicator capable of influencing across functions and organizational levels.