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

Bostonscientific

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profile Job Location:

Toronto - Canada

profile Monthly Salary: Not Disclosed
Posted on: 5 hours ago
Vacancies: 1 Vacancy

Job Summary

Additional Locations:Canada-ON-Ottawa; Canada-ON-Mississauga; Canada-ON-Toronto

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll 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. 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 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 regulatoryand market accessstrategies that promotetimelyworldwideapprovaladoptionand reimbursementof IO&E productsincluding medical devices drug/device combination products and pharmaceuticals.

  • Develop andmaintainprograms 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 Regulatoryand HEMAteam toaccomplishdivisional goals and strategies.

  • Provideexpertisein interpreting regulations and drive implementation across the organization.

  • Oversee regulatory aspects of field actions recalls and post market events audits ensuringtimelyand effective execution in alignment with global health authority requirements.

  • Collaborate with cross-functional teams to develop clinical strategies and economic evidencedemonstratingvalue of IO&E technologies to support market access

  • Engage withglobalpayers 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 todemonstratevalue 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 ensuretimelyproduct approvals and compliance.

  • Lead a diverse global team with complex initiatives;foster an inclusive patient-centric culture and support career development across teams; attract andretainworld-class talent.

Required qualifications:

  • Bachelors degree;Advanced degree preferred.

  • 15years of experience in Regulatory Affairsand/or HEMAwithinthe pharmaceuticaland/ormedical device industry.

  • 10years of direct management experience leading global teams.

  • Proven leadership in developing and executing globalRegulatory andHEMA strategies.

  • Expertisein regulatory pathways including PMAIDE510(k) EU MDRNDA IND FDA pre-submissionsand international registrationsincluding China and Japan.

  • Demonstratedexpertisein global healthcare systems / markets and economics of healthcare reimbursementwitha focusonUShealthcare andCMS.

  • 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.

Preferred qualifications:

  • Strong leadership skills with high customer focus.

  • High degreeofintegrity 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$197900

Maximum Salary: CAD$392800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see -- 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.

Compensation for hourly non-sales roles may also include variable compensation from time to time (e.g. any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for salaried non-sales roles may also include variable compensation i.e. annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).

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) isnt just business its personal. And if youre 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!


Required Experience:

Exec

Additional Locations:Canada-ON-Ottawa; Canada-ON-Mississauga; Canada-ON-TorontoDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performi...
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Key Skills

  • Proofreading
  • Adobe Acrobat
  • FDA Regulations
  • Manufacturing & Controls
  • Biotechnology
  • Clinical Trials
  • Research & Development
  • GLP
  • cGMP
  • Product Development
  • Chemistry
  • Writing Skills

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