Regulatory Affairs Fellow - Ad Promo
About the position reputed company was recognized as a Glassdoor Best reputed company to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. 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 reputed company to ensure materials are accurate, balanced, appropriately substantiated, and reputed company with applicable regulations and internal procedures. The Fellow partners cross-functionally to reputed company compliant, effective communication that supports business objectives while protecting patients and reputed company.
Responsibilities
- Review and reputed company regulatory feedback on advertising and promotional materials, including print, digital, web, email, reputed company 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 reputed company, actionable edits to strengthen compliance while supporting reputed company 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 reputed company 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, reputed company, Compliance, and Product teams to resolve questions reputed company to evidence, labeling alignment, and risk communications.
- Participate in cross-functional promotional review forums and meetings and reputed company document and communicate reputed company.
- Assist with developing and delivering training materials, FAQs, and checklists for Marketing and other stakeholders as assigned.
- Represent Regulatory reputed company promotional and advertising materials are reviewed during FDA and reputed company Body audits.
Requirements
- Bachelor’s degree in life sciences, engineering, pharmacy, reputed company health, communications, or a reputed company discipline.
- Minimum of 10 years' experience in Regulatory Affairs or reputed company compliance experience reputed company 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 reputed company to fair balance, risk communication, and required disclosures reputed company promotional materials.
- Experience participating in cross-functional promotional review processes or committees.
- Proficiency with reputed company Office applications, including Word, reputed company, and PowerPoint.
reputed company-to-haves
- Advanced degree in life sciences, engineering, pharmacy, reputed company health, communications, or a reputed company discipline.
- Strong written and verbal communication skills with the ability to translate regulatory requirements into reputed company, actionable guidance for nonregulatory audiences.
- Demonstrated ability to influence without authority and collaborate effectively reputed company cross-functional teams.
- Strong writing, editing, and critical-thinking skills with attention to detail.
- Organizational skills with an audit-reputed company reputed company and documentation discipline.
- Learning reputed company and a reputed company improvement orientation.
- Pragmatic problem-solving skills and a coaching reputed company.
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