Description
A fast-paced, fast-growth medical device company is seeking a Manager of Regulatory Affairs to join their growing team. The Manager of Regulatory Affairs will be responsible for implementing and delivering regulatory strategies to gain clearances and approvals of medical devices in the U.S., EU and other international markets.Responsibilities include:
- Prepare regulatory documentation for submission to regulatory agencies and advise on regulatory strategy. (510k, CE Mark, etc)
- Compile necessary documentation for license renewals and registrations
- Review labeling for compliance with regulatory requirements
- Review changes to existing products
- Timely registrations of facility
- Provide regulatory guidance on R&D product development teams
- Review marketing material for compliance
Qualifications:
- B.S. - (technical field a plus)
- 3+ years regulatory affairs experience
- Knowledge of US and international regulatory requirements
- Experience with 510(k) and CE Mark processes/submissions
To find out more about Real please visit www.realstaffing.com