Principal Regulatory Affairs Specialist

Additional Location(s): US-MN-Maple Grove

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

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.       

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.

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. 

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 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

Required qualifications:

● 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

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 and coaching mindset

#LI-Hybrid

Requisition ID: 625973

Minimum Salary: $102100 

Maximum Salary: $194000 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.