Vice President, Regulatory Affairs and Health Economics and Market Access
3 weeks ago
Vice President, Regulatory Affairs and Health Economics and Market Access - IO&E Additional Locations: Canada-ON-Ottawa; Canada-ON-Mississauga; Canada-ON-Toronto Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high‑performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. 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. 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. Requisition ID: 619519 Minimum Salary: CAD$197,900 Maximum Salary: CAD$392,800 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com – will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem‑solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you Seniority level Not Applicable Employment type Full‑time Job function Other Industries Medical Equipment Manufacturing #J-18808-Ljbffr
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Ottawa, Canada Boston Scientific Gruppe Full timeVice President, Regulatory Affairs and Health Economics and Market Access - IO&E Onsite Location(s): Ottawa, ON, CA Additional Locations: Canada-ON-Ottawa; Canada-ON-Mississauga; Canada-ON-Toronto Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all...
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Ottawa, Ontario, Canada Boston Scientific Full timeBachelor'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...
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