Associate Senior Fellow, Regulatory Affairs

Boston Scientific•Arden Hills, MN

1d•$137,700 - $261,600•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

Act as the corporate regulatory SME for advertising, promotional, sales enablement, and training materials, providing timely and practical guidance to business units and functional partners.
Interpret and apply FDA and EU regulatory requirements and related guidance to content development and review, ensuring compliance for intended audiences and markets.
Advise on compliant product claims, including performance, clinical, comparative, safety, and indications or contraindications-related statements, and appropriate claim substantiation strategies.
Support compliant use of labeling, IFU excerpts, clinical data, testimonials, graphics, and digital content, including web, email, social, and webinars, in promotional contexts.
Establish and lead a regulatory community of practice to maintain consistent review expectations, decision frameworks, and documentation practices across business units.
Provide oversight and consultation for complex or high-risk materials, including new product launches, high-visibility campaigns, and novel claim types.
Identify trends and recurring compliance issues and recommend mitigations and continuous improvements to content development and review workflows.
Own global processes and standard operating procedures (SOPs) and work instructions related to promotional material review and approval, including change control, documentation, and audit readiness.
Define standards for content review pathways, escalation routes, evidence requirements, and record retention.
Ensure processes align with quality system expectations and are scalable across regions and business units.
Develop and maintain role-based training requirements and curricula for Regulatory Affairs and Marketing professionals related to advertising and promotion compliance.
Create tools and job aids, including claim libraries, substantiation checklists, decision trees, and templates, to drive consistent, compliant execution.
Deliver training sessions, office hours, and onboarding modules; assess effectiveness and refine training based on metrics and feedback.
Partner closely with business unit regulatory teams and provide timely and practical guidance to business units and functional partners.
Partner closely with Marketing to ensure understanding of regulatory requirements and their application to content planning, concepting, and development.
Collaborate with Legal, Medical, Clinical, Quality, Compliance, and Commercial or Sales leadership to align interpretations and manage risk.
Support internal and external audits and inspections by ensuring robust documentation and readiness for promotional material processes.