Sr. Director, Regulatory Affairs, Vascular

Abbott•Santa Clara, CA

4d•$218,700 - $437,300•Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: * Career development with an international company where you can grow the career you dream of. * Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan. * An excellent retirement savings plan with high employer contribution * Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree * A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. * A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. 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.

Requirements

Bachelor’s degree required.
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.

Nice To Haves

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)

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.