Sr. Director, Regulatory Affairs, Vascular

THE OPPORTUNITY

Own the worldwide, end-to-end regulatory strategy across multiple therapy areas supporting the Vascular $3B portfolio. Directly influence pipeline, investment, and global market access decisions. This is an opportunity to build the next-generation regulatory operating model. Serve as the regulatory leader across the Vascular portfolio, driving portfolio-level strategy, prioritization, and executive decision-making. This role shapes how regulatory strategy influences business investments, pipeline sequencing, and global market access, while leading teams across pre-market, on-market, and franchise-aligned functions.

KEY RESPONSIBILITIES

• Lead regulatory strategy across vascular franchises.
• Define governance and decision-making frameworks.
• Identify and mitigate regulatory risks while aligning with executive leadership.
• Drive transformation of the regulatory operating model.
• Build, develop, and lead high-performing leadership teams.

KEY SUCCESS FACTORS

• Portfolio optimization and strategic alignment.
• Executive influence on critical business decisions.
• Scalable organizational design and operating models.
• Sustained regulatory success and execution excellence.

CORE LEADERSHIP & FUNCTIONAL COMPETENCIES

• Executive leadership
• Strategic planning
• Organizational design
• Enterprise influence

REQUIRED QUALIFICATIONS

• Education: Bachelor’s degree required.
• Experience: Minimum of 10 years of relevant industry experience.
• Demonstrated experience in medical devices, including permanent implants, disposables, and combination products (device-drug), spanning the full product lifecycle.
• Proven track record of enterprise-wide leadership and cross-functional influence.
• Experience influencing executive-level decision-making and driving strategic initiatives.
• Strong working knowledge of global regulatory requirements, including U.S. FDA regulations (PMAs, including original submissions and supplements, and 510(k)s), Notified Body requirements, and CE Marking.
• Experience with other international regulatory agencies, including Japan PMDA, China NMPA/CMDE, and South Korea MFDS, is preferred.
• Excellent communication, organizational leadership, and project/program management skills.
• Ability and willingness to travel domestically and internationally up to 25% of the time.

PREFERRED QUALIFICATIONS

• 15+ years of industry experience.
• Advanced degree (MS, PhD, MBA).
• RAC certification or equivalent.
• Experience in vascular or cardiovascular devices.
• Experience in global regulatory environments (FDA, EU MDR).