Principal Regulatory Affairs Specialist - Advertising & Promotion

Regulatory Affairs Principal

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.

This Regulatory Affairs Principal 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.

This role follows a hybrid work model requiring employees to be in our 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:

• 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.
• Establish and lead advertising and promotional training, as appropriate.
• Establish and lead a peer team to support the review of advertising and promotional materials.
• Participate in and contribute to the continuous improvement of Boston Scientific processes for 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.
• 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 data visualizations for cross-functional review.
• Follow applicable SOPs and work instructions for promotional material review and approval and ensure records are complete and audit-ready.
• Identify recurring issues, propose mitigations, and contribute to updates of 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 communication.
• Participate in cross-functional promotional review meetings and communicate decisions with clear rationale.
• Assist in developing and delivering training materials, FAQs, and checklists for stakeholders.
• Represent Regulatory Affairs during internal and external audits, including FDA and notified body inspections.

Required qualifications:

• Bachelor's degree in business, marketing, life sciences, engineering, pharmacy, public health, communications, or a related discipline.
• Minimum of 5 years' experience in marketing, labeling, training, Regulatory Affairs, or related compliance roles within the medical device industry, including review of advertising, promotional, sales, and training materials.
• Demonstrated knowledge of FDA and EU regulatory frameworks impacting product promotion and communications.
• Experience evaluating product claims for alignment with cleared or approved indications for use.
• Experience assessing clinical, performance, and bench data to support promotional claims.
• Experience applying regulatory requirements related to fair balance, risk communication, and required disclosures.
• Experience participating in cross-functional promotional review processes or committees.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.

Preferred qualifications:

• Demonstrated ability to influence without authority and collaborate effectively across multiple products and cross-functional teams.
• Strong written and verbal communication skills, with the ability to translate regulatory requirements into clear, actionable guidance for nonregulatory audiences.
• Ability to manage multiple projects and meet deadlines in a fast-paced, cross-functional environment.
• Strong organizational skills with an audit-ready mindset.
• Learning agility and a continuous improvement orientation.
• Pragmatic problem-solving skills and a coaching mindset.