Regulatory Affairs Fellow - Ad Promo

Boston Scientific•Arden Hills, MN

7h•$125,800 - $239,000•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. The Regulatory Affairs Fellow supports the review and approval of advertising, promotional, sales support, and training materials for Electrophysiology medical devices. This role applies a risk-based regulatory mindset to ensure materials are accurate, balanced, appropriately substantiated, and aligned with applicable regulations and internal procedures. The Fellow partners cross-functionally to enable compliant, effective communication that supports business objectives while protecting patients and the company.

Requirements

Bachelor’s degree in life sciences, engineering, pharmacy, public health, communications, or a related discipline.
Minimum of 10 years' experience in Regulatory Affairs or related compliance experience within the medical device industry and experience directly reviewing advertising, promotional, sales, and training materials for medical devices.
Demonstrated working knowledge of FDA and EU regulatory frameworks impacting medical device promotion and communications.
Experience evaluating product claims for alignment with cleared or approved indications for use.
Experience assessing clinical, performance, and bench data to substantiate promotional claims.
Experience applying regulatory requirements related to fair balance, risk communication, and required disclosures within promotional materials.
Experience participating in cross-functional promotional review processes or committees.
Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.

Nice To Haves

Advanced degree in life sciences, engineering, pharmacy, public health, communications, or a related discipline.
Strong written and verbal communication skills with the ability to translate regulatory requirements into clear, actionable guidance for nonregulatory audiences.
Demonstrated ability to influence without authority and collaborate effectively within cross-functional teams.
Strong writing, editing, and critical-thinking skills with attention to detail.
Organizational skills with an audit-ready mindset and documentation discipline.
Learning agility and a continuous improvement orientation.
Pragmatic problem-solving skills and a coaching mindset.

Responsibilities

Review and provide regulatory feedback on advertising and promotional materials, including print, digital, web, email, social media, video, webinars, sales aids, and training or education materials.
Assess proposed product claims for alignment with cleared or approved indications.
Evaluate content for appropriate context, fair balance, and compliant presentation of benefits, risks, limitations, and required disclosures.
Recommend clear, actionable edits to strengthen compliance while supporting commercial objectives.
Confirm that promotional claims are supported by appropriate clinical, performance, or bench evidence and are referenced correctly.
Escalate high-risk or novel claims, comparative statements, testimonials, and graphics or data visualizations for cross-functional review.
Follow applicable SOPs and work instructions for promotional material review and approval; ensure review records are complete, appropriately documented, and stored.
Contribute to continuous improvement by identifying recurring issues, proposing mitigations, and supporting updates to templates and job aids.
Partner with Marketing and content creators early in the development process to guide compliant concepts and messaging.
Collaborate with Medical, Clinical, Legal, Quality, Compliance, and Product teams to resolve questions related to evidence, labeling alignment, and risk communications.
Participate in cross-functional promotional review forums and meetings and clearly document and communicate decisions.
Assist with developing and delivering training materials, FAQs, and checklists for Marketing and other stakeholders as assigned.
Represent Regulatory when promotional and advertising materials are reviewed during FDA and Notified Body audits.