Senior Manager Regulatory Ad/Promo

Senior Manager Regulatory Ad/Promo EPM Scientific - 3.3 Minneapolis, MN Job Details 2 days ago Qualifications Compliance risk assessment Bachelor's degree in communications Drug regulation Incident Escalation Collaboration with product development teams Bachelor's degree in engineering Public Health Compliance documentation Communications Biomedical regulatory compliance Bachelor's degree in public health Regulatory compliance analysis Senior level Escalation handling Content review Communication skills Editing FDA regulations Audit support 10 years Full Job Description A leading global medical device company is seeking a Regulatory Affairs Senior Manager to support the review and approval of advertising, promotional, sales, and training materials for its medical device portfolio. This role applies a risk‑based regulatory mindset to ensure content is accurate, balanced, well‑substantiated, and compliant with FDA, EU, and internal requirements. The Regulatory Affairs Senior Manager will be responsible for… 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 The Regulatory Affairs Senior Manager should have the following qualifications: 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