Senior Manager Regulatory Ad/Promo

Senior Manager Regulatory Ad/Promo (PR/592530) Minneapolis, Minnesota

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.
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
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
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

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