Regulatory Affairs Fellow - Ad Promo

Additional Location(s): US-MA-Waltham

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, you will have the opportunity to leverage your skills in teams of diverse and high‑performing employees, tackling important challenges in the health industry. We provide the latest tools, information, and training to help you advance your career and achieve your ambitions.

About The Role
The Regulatory Affairs Fellow supports the review and approval of advertising, promotional, sales support, and training materials for Electrophysiology medical devices. The 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.

Work Model, Sponsorship
This role follows a hybrid work model requiring employees to be in the local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your Responsibilities Will Include

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.

Required Qualifications

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 non‑regulatory 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.

Compensation
Minimum Salary: $131,700
Maximum Salary: $250,200. Compensation will vary based on actual location and other pertinent factors. Boston Scientific provides a range of core and optional employee benefits; details are available at the company benefits portal.

Equal Employment Opportunity Statement
Boston Scientific Corporation is an equal opportunity employer. The Company will ensure recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made 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.

COVID‑19 Vaccination Requirement
Certain positions may require acceptable proof of COVID‑19 vaccination status. Candidates will be notified of the requirement if it applies to the role. Boston Scientific complies with applicable state and federal law and healthcare credentialing requirements.

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