Principal Regulatory Affairs Specialist - Advertising & Promotion (Ad Promo)
$102,100–$194,000 year
Hybrid · Maple Grove, Minnesota, United States
Job Summary
Principal Regulatory Affairs Specialist - Advertising & Promotion for medical devices used in interventional cardiology. Responsible for reviewing and approving advertising, promotional, sales support and training materials; ensure claims are supported and balanced; collaborate with Marketing, Medical, Legal, and Quality/Compliance; develop trainings and checklists; participate in audits and cross-functional reviews; ensure SOPs and templates are updated; drive compliant messaging early in development; guidance on evidence, labeling alignment and risk communication; hybrid work model with in-office presence at least three days weekly.
Required Qualifications
- Bachelor’s degree in life sciences, engineering, pharmacy, public health, communications or related discipline
- Minimum of 5 years' experience in regulatory affairs or related compliance roles within the medical device industry
- Experience with FDA and EU regulatory frameworks for product promotion and communications
- Experience evaluating product claims for alignment with indications for use
- Experience with clinical, performance and bench data to support promotional claims
- Experience with fair balance, risk communication and required disclosures
- Experience participating in cross-functional promotional review processes or committees
- Proficiency with Microsoft Office (Word, Excel, PowerPoint)
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