Senior Manager Regulatory Affairs Ad/Promo - Medical Device

Overview
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
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

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
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

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