What are the responsibilities and job description for the Principal Regulatory Affairs Specialist position at EPM Scientific?
A leading global medical device company is seeking a Regulatory Affairs Principal to support the review and approval of advertising, promotional, sales, and training materials for its interventional cardiology 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 Principal 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 Principal should have the following qualifications:
- Bachelor's degree in life sciences, engineering, public health, communications, or related field
- 5 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