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

If you are a candidate based in Canada, please proceed to submit your application to this requisition (619519). If you are a candidate based in the United States, please redirect to submit your application to requisition 618291. Thank you for your cooperation!

About the role

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. 

Your responsibilities will include:  

• 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. 

Required qualifications:  

• 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. 

Preferred qualifications: 

• 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.