Systems Engineer
Artera.net
Senior Regulatory Labeling Specialist, Ad/Promo
Medtronic
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $93,600 - $140,400 per year
Job Level
Senior
About the role
- Support review of advertising and promotional material to ensure that it meets all medical, legal, and regulatory (MLR) process requirements.
- Facilitate review meetings online and offline coordination with authors, reviewers/approvers to get content approved to support business needs.
- Act as SME for Neurovascular Ad Promo process, providing guidance to authors and reviewers on regulatory and internal policy requirements.
- Support the preparation of US and International promotional labeling material, including the creation of a claims matrix database and claims objects.
- Lead AI/ML adoption in content and claims management to support automation and enhance process efficiency.
- Drive the pending review/approval requests for Ad Promo, and work with reviewers to push the approvals in a timely fashion.
- Create reports & metrics to provide visibility to management on cycle times of review/approval
- Process improvement: work with a cross-functional team to map the process, identify bottlenecks, provide solutions, and author new process documents
- Monitor changes and compliance with applicable FDA and international regulatory laws/standards and the Medtronic Code of Conduct
- Provide training support for new authors, asset owners, and reviewers/approvers
- Facilitate review/approval system changes and user support
Requirements
- Minimum Requirements Bachelor’s degree in science, communication, or a healthcare-related field
- 4 years of medical device experience, including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling, or an advanced degree with 2 years’ experience
- Nice to Have: US and International medical device industry experience in Advertising & Promotional labeling
- Proficiency with Veeva PromoMats, Ad Promo/MLR claims, and material review and approval systems
- Excellent communication & organizing skills
- Knowledge of FDA, EU, and TGA requirements
- Knowledge of Neurovascular brain therapies
- Experience of working with 510(k) and/or IDE and/or PMA devices
- Product Labeling requirements and standards
- Technical Writing experience
- Systems Knowledge, such as content management systems, document management, and workflow design
- Business system analysis
