Regulatory Affairs Fellow - Ad Promo

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.

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.
• Aid in 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.

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.

Preferred Qualifications

• 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.