Regulatory Affairs Analyst II
Danaher
- Chaska, MN
- Permanent
- Full-time
- Create and manage Technical Files in compliance with IVDD and IVDR.
- Review Protocols, data and write reports to support regulatory submissions.
- Support FDA submission applications for new IVD products.
- Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.
- Be involved in cross-functional projects contributing to problem solving and continuous improvement initiatives.
- Bachelor's Degree with 2+ years of experience in Life Sciences/Similar fields or a Master's degree
- Excellent written and communication skills.
- Ability to work in a very busy environment and to manage change effectively.
- Knowledge of FDA, registrations and commercialization of medical devices.
- Demonstrated knowledge and understanding of global regulations and guidelines governing in-vitro diagnostics.
- RAC certificate
- IVDR regulations knowledge