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Regulatory Affairs Specialist
2 months ago
Katalyst Healthcares and Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to lead our global and US submissions for medical devices.
Responsibilities:- Prepare and manage submissions for 510k and IVD/IVDR related products
- Handle pre and post market submissions, ensuring compliance with regulatory requirements
- Manage all aspects of IVDD/IVDR requirements, including quality system auditing
- Lead Health Canada and international device licensing efforts
- Support new product submissions and product technical file development and maintenance
- 4+ years of experience in Regulatory Affairs, specifically in the IVD space
- Previous experience with 510k submissions, Health Canada, International Device Submissions Licensing and Registration
- Knowledge of IVDD/IVDR and quality system auditing
- CQA and RAC certifications a plus
