Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Memphis, TN 37501
About the Job
Responsibilities:
- Lead preparation for global and US submissions such as 510k and IVD/IVDR related products.
- Handle pre and post market submissions.
- Manage all aspects of IVDD/IVDR requirements.
- Lead Health Canada and international device licensing.
- Support new product submissions.
- Support product technical file development and maintenance.
- MUST HAVE 4+ years of Regulatory experience in the IVD space.
- Previous experience with 510k submissions, Health Canada, International Device Submissions Licensing and Registration experience.
- Knowledge of IVDD/IVDR.
- Quality system auditing experience preferred.
- CQA and RAC certifications preferred.
Source : Katalyst Healthcares & Life Sciences
