Associate Senior Fellow, Regulatory Affairs
Minnesota Jobs, Osseo, MN, United States
Associate Senior Fellow, Regulatory Affairs
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. About the role: Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. We are seeking an Associate Senior Fellow, Regulatory Affairs, to serve as the promotional, educational, sales support and training (PSST) materials lead and corporate subject matter expert (SME) for regulatory compliance of advertising, promotional, sales, and training materials. This role supports medical devices, pharmaceutical, and combination products across multiple business units. In this role, you will provide strategic and tactical regulatory guidance to ensure materials are accurate, balanced, substantiated, and aligned with applicable FDA and EU requirements. You will drive consistency in content review practices, own and continuously improve global processes, and develop training programs for Regulatory Affairs and Marketing teams. You will partner closely with Marketing and cross-functional stakeholders to enable compliant, effective content development across the product lifecycle. Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. This role may be based in Arden Hills or Maple Grove, Minnesota, or Marlborough, Massachusetts. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include: Corporate SME: Advertising, promotion, sales, and training content Review governance and consistency across business units Global process ownership Training and capability building Strategic cross-functional partnership Required qualifications: Bachelor's degree in life sciences, engineering, pharmacy, public health, or a related field. Minimum of 10 years' experience in regulatory affairs or a related discipline within medical devices, pharmaceutical, or combination products, including direct involvement in review of promotional, sales, and training materials. Demonstrated working knowledge of FDA and EU regulatory frameworks impacting product promotion and communications. Experience reviewing and providing regulatory guidance on advertising, promotional, sales, or training materials. Experience interpreting and applying regulatory requirements to product claims, including clinical, performance, safety, and comparative claims. Experience developing or supporting regulatory processes, SOPs, or governance models related to promotional material review. Experience developing and delivering training programs or materials related to regulatory compliance. Preferred qualifications: Proven ability to influence without authority and operate as a corporate SME across multiple business units. Strong written and verbal communication skills with the ability to translate regulations into clear, actionable guidance for nonregulatory audiences. Experience working effectively in a matrixed environment and collaborating across cross-functional teams. Experience operating within a formal promotional material review committee or cross-functional review process in a regulated environment. Experience with global product portfolios and multiregional content deployment strategies. Familiarity with digital marketing compliance considerations and content governance models. Experience leading SOP or process creation, global harmonization efforts, and change management. Refer to ID 86680938 when applying
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. About the role: Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. We are seeking an Associate Senior Fellow, Regulatory Affairs, to serve as the promotional, educational, sales support and training (PSST) materials lead and corporate subject matter expert (SME) for regulatory compliance of advertising, promotional, sales, and training materials. This role supports medical devices, pharmaceutical, and combination products across multiple business units. In this role, you will provide strategic and tactical regulatory guidance to ensure materials are accurate, balanced, substantiated, and aligned with applicable FDA and EU requirements. You will drive consistency in content review practices, own and continuously improve global processes, and develop training programs for Regulatory Affairs and Marketing teams. You will partner closely with Marketing and cross-functional stakeholders to enable compliant, effective content development across the product lifecycle. Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. This role may be based in Arden Hills or Maple Grove, Minnesota, or Marlborough, Massachusetts. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include: Corporate SME: Advertising, promotion, sales, and training content Review governance and consistency across business units Global process ownership Training and capability building Strategic cross-functional partnership Required qualifications: Bachelor's degree in life sciences, engineering, pharmacy, public health, or a related field. Minimum of 10 years' experience in regulatory affairs or a related discipline within medical devices, pharmaceutical, or combination products, including direct involvement in review of promotional, sales, and training materials. Demonstrated working knowledge of FDA and EU regulatory frameworks impacting product promotion and communications. Experience reviewing and providing regulatory guidance on advertising, promotional, sales, or training materials. Experience interpreting and applying regulatory requirements to product claims, including clinical, performance, safety, and comparative claims. Experience developing or supporting regulatory processes, SOPs, or governance models related to promotional material review. Experience developing and delivering training programs or materials related to regulatory compliance. Preferred qualifications: Proven ability to influence without authority and operate as a corporate SME across multiple business units. Strong written and verbal communication skills with the ability to translate regulations into clear, actionable guidance for nonregulatory audiences. Experience working effectively in a matrixed environment and collaborating across cross-functional teams. Experience operating within a formal promotional material review committee or cross-functional review process in a regulated environment. Experience with global product portfolios and multiregional content deployment strategies. Familiarity with digital marketing compliance considerations and content governance models. Experience leading SOP or process creation, global harmonization efforts, and change management. Refer to ID 86680938 when applying