Additional Location(s): US-MA-Waltham
About the role:
The Regulatory Affairs Fellow supports the review and approval of advertising, promotional, sales support, and training materials for Electrophysiology medical devices. This 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:
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 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 nonregulatory 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.
Requisition ID: 632002
Minimum Salary: $131700
Maximum Salary: $250200
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.
