Principal Regulatory Affairs Specialist

Boston Scientific•Maple Grove, MN

1d•$102,100 - $194,000•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. 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. Work model, sponsorship: At Boston Scientific, we value collaboration and synergy. 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.

Requirements

Bachelor’s degree in life sciences, engineering, pharmacy, public health, communications or a related discipline
Minimum of 5 years' experience in regulatory affairs or related compliance roles within the medical device industry, including direct 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

Nice To Haves

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 and 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 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 and/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 development 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