Regulatory Affairs Specialist

4 weeks ago


Laguna Hills, United States Insight Global Full time

Support and prepare documentation for regulatory submissions and registrations (FDA and EU regulatory entities)
IDE, PMA, 510 (k), Design Dossiers, Technical Files.
Maintain regulatory Technical Files
Review changes to Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
Support communication with FDA

Experience with IDE's, class III catheter
Experience with changes to existing products
3+ years of experience in regulatory affairs
3+ years of experience with regulatory submissions (specifically in the United States, EU and CAN)
3+ years of experience writing submissions, authoring technical sections, and collecting technical reports (ie. PMA , IDE, 510K, CE-marking submission, Technical documentation)
Current knowledge of FDA Guidelines, Medical Device Regulations , ISO 13485, and standards applicable to company products.
Exposure to quality management systems
Bachelor's Degree



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