Senior Manager Regulatory Affairs Ad/Promo - Medical Device

Responsibilities

• Reviewing promotional materials across print, digital, social, video, and training formats
• Assessing product claims for alignment with cleared/approved indications
• Ensuring fair balance, proper risk communication, and compliant disclosures
• Recommending actionable edits that support both compliance and commercial goals
• Escalating high-risk or novel claims for cross-functional review
• Maintaining complete, audit-ready promotional review documentation
• Collaborating with Medical, Clinical, Legal, Quality, and Product teams
• Participating in promotional review meetings and communicating decisions clearly
• Representing Regulatory Affairs during internal and external audits

Requirements

• Bachelor's degree in life sciences, engineering, public health, communications, or related field
• 10+ years of regulatory or compliance experience in the medical device industry, including direct ad/promo work
• Strong knowledge of FDA and EU regulations impacting product promotion
• Experience evaluating claims and supporting evidence
• Understanding of fair balance, risk communication, and required disclosures
• Experience in cross-functional promotional review processes