Sr. RA Ad/promo Specialist

Title: Sr. RA Ad/promo Specialist
Location: Irvine, CA

JobDescription:

5+ years of medical device experience including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling 2. Support review of advertising and promotional material to ensures that it meet all medical, legal, and regulatory (MLR) process requirements. 3. Facilitate review meetings online and offline coordination with authors, reviewers/approvers to get content approved to support business needs. 4. Act as SME for Neurovascular Ad Promo process, providing guidance to authors and reviewers on regulatory and internal policy requirements. 5. Support preparation of US and International promotional labeling material including creation of claims matrix database and claims objects. 6. Lead AI/ML adoption in content and claims management to support automation and enhance process efficiency. 7. Drive the pending review/approval requests for Ad Promo, work with reviewers to push the approvals in a timely fashion. 8. Create reports & metrics to provide visibility to management on cycle times of review/approval 9. Process improvement: work with cross-functional team to map the process, identify bottlenecks, provide solutions, and author new process documents