JOB DESCRIPTION: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.
WHAT YOU'LL WORK ON: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)
APPLY NOW:Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $218,700.00 - $437,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Regulatory Operations
DIVISION:AVD Vascular
LOCATION:United States > Santa Clara : Building B - SC
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 25 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Keyboard use (greater or equal to 50% of the workday)
