Vice President, Regulatory Affairs and Health Economics and Market Access - IO&E

Boston Scientific•Maple Grove, MN

47d•$215,100 - $408,700

About The Position

Boston Scientific is seeking a strategic and visionary leader to serve as Vice President of Regulatory Affairs and Health Economics and Market Access (HEMA) for the Interventional Oncology & Embolization (IO&E) division. This role will integrate global Regulatory Affairs and HEMA leadership to drive innovation, ensure compliance, and enable market access for transformative IO&E technologies. This leader will play a critical role on the IO&E leadership team and will have a direct impact on our business, strategies, and competitive landscape.

Requirements

Bachelor's degree required; Advanced degree preferred.
15+ years of experience in Regulatory Affairs and/or HEMA within the pharmaceutical and/or medical device industry.
10+ years of direct management experience leading global teams.
Proven leadership in developing and executing global Regulatory and HEMA strategies.
Expertise in regulatory pathways including PMA, IDE, 510(k), EU MDR, NDA, IND, FDA pre-submissions and international registrations including China and Japan.
Demonstrated expertise in global healthcare systems / markets and economics of healthcare reimbursement with a focus on US healthcare and CMS.
Experience with device and combination products, specifically with cancer therapies.
Established relationships with global regulators and payers.
Demonstrated ability to influence key economics purchasers including customers, payers, and governments.
Ability to interpret regulations and apply to business needs.
Demonstrated understanding of commercial, operational, and functional aspects of the business and success in managing complex matrixed organizations and influencing cross-functional teams.
Ability to travel domestically and/or internationally as required.

Nice To Haves

Strong leadership skills with high customer focus.
High degree of integrity and professionalism.
Ability to build relationships and influence internal and external stakeholders.
Experience in IO&E or related interventional therapies is highly desirable.

Responsibilities

Champion regulatory and market access strategies that promote timely worldwide approval, adoption and reimbursement of IO&E products including medical devices, drug/device combination products, and pharmaceuticals.
Develop and maintain programs, policies, and procedures ensuring compliance with international and governmental regulatory standards.
Lead regulatory due diligence for mergers, acquisitions, and partnerships with assessing regulatory strategy, risk, and compliance to inform investment decisions and integration planning.
Lead a global Regulatory and HEMA team to accomplish divisional goals and strategies.
Provide expertise in interpreting regulations and drive implementation across the organization.
Oversee regulatory aspects of field actions, recalls, and post market events, audits, ensuring timely and effective execution in alignment with global health authority requirements.
Collaborate with cross-functional teams to develop clinical strategies and economic evidence demonstrating value of IO&E technologies to support market access
Engage with global payers, providers, and policy makers to shape access and coverage policies.
Ensure integration of HEMA insights into product development, commercialization, and lifecycle management.
Drive innovative approaches to demonstrate value and support health system decision-making.
Represent Boston Scientific in interactions with regulatory authorities and industry associations.
Collaborate with corporate, divisional, and regional partners to ensure timely product approvals and compliance.
Lead a diverse, global team with complex initiatives; foster an inclusive, patient-centric culture and support career development across teams; attract and retain world-class talent.