Principal Regulatory Affairs Specialist - Advertising & Promotion

4w4 weeks ago

Boston Scientific

Arden Hills, US · Full-time · $102,100 – $194,000

About this role

This Principal Regulatory Affairs Specialist role supports the review and approval of advertising, promotional, sales support, and training materials for medical devices used in interventional cardiology. The role applies a risk-based regulatory mindset to help ensure materials are accurate, balanced, appropriately substantiated, and aligned with applicable regulations and internal procedures.

As a key regulatory partner to the commercial organization, this role helps enable compliant and effective communications that support business objectives while protecting patients and the company. Day-to-day responsibilities include serving as a collaborative liaison to the Cardiac Rhythm Management and Diagnostics commercial team in the development, review, and approval of advertising and promotional materials.

You will participate in cross-functional promotional review meetings and communicate decisions with clear rationale, collaborating with Medical, Clinical, Legal, Quality, Compliance, and Product teams. The role also involves establishing and leading advertising and promotional training, as well as leading a peer team to support the review of advertising and promotional materials.

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. Here, you'll be supported in progressing whatever your ambitions, with access to the latest tools, information, and training to advance your skills and career.

Requirements

Ability to apply a risk-based regulatory mindset to ensure materials are accurate, balanced, appropriately substantiated, and aligned with applicable regulations and internal procedures.
Experience in the review and approval of advertising, promotional, sales support, and training materials for medical devices.
Strong knowledge of regulatory requirements for promotional materials in the pharmaceutical or medical device industry.
Ability to assess proposed product claims for alignment with cleared or approved indications for use.
Experience evaluating content for appropriate context, fair balance, and compliant presentation of benefits, risks, limitations, and required disclosures.
Ability to recommend clear, actionable edits to strengthen compliance while supporting commercial objectives.
Experience collaborating with cross-functional teams including Medical, Clinical, Legal, Quality, Compliance, and Product teams.
Familiarity with SOPs and work instructions for promotional material review and approval, ensuring records are complete and audit-ready.

Responsibilities

Serve as a collaborative partner and liaison to the Cardiac Rhythm Management and Diagnostics (CRMDx) commercial team in the development, review, and approval of advertising and promotional materials.
Provide regulatory review and feedback for advertising and promotional materials, including print, digital, web, email, social media, video, webinars, sales aids, and training materials.
Assess proposed product claims for alignment with cleared or approved indications for use and evaluate content for appropriate context, fair balance, and compliant presentation of benefits, risks, limitations, and required disclosures.
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 data visualizations for cross-functional review.
Establish and lead advertising and promotional training, and lead a peer team to support the review of advertising and promotional materials.
Partner with Marketing and content creators early in the development process to guide compliant concepts and messaging.
Participate in cross-functional promotional review meetings and communicate decisions with clear rationale.

Benefits

Hybrid work model requiring employees to be in the local office at least three days per week.
Access to the latest tools, information, and training to advance your skills and career.
Opportunity to work in teams of diverse and high-performing employees tackling important health industry challenges.
Culture recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list.