Associate Senior Fellow, Regulatory Affairs

Additional Location(s): US-MN-Arden Hills; US-MA-Marlborough; US-MN-Maple Grove

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.       

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

● 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.

Review governance and consistency across business units

● 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.

Global process ownership

● 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.

Training and capability building

● 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.

Strategic cross-functional partnership

● 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.

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.

#LI-Hybrid

Requisition ID: 626548

Minimum Salary: $137700 

Maximum Salary: $261600 

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.

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

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.