Regulatory Affairs Associate - Sylmar, CA

Description

Responsible for filing necessary regulatory applications and supporting interactions with U.S. and international regulatory authorities for products requiring governmental approval. Authoring and submitting U.S. PMA supplements (30-day Notices, Real-Time Reviews, 180-Day Supplements, Annual Reports), as well as supporting EU MDR Technical Documentation updates, change assessments, and Notified Body submissions. Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing and design changes for Class III implantable medical devices, including assessment of regulatory impact under both FDA and EU MDR requirements.

Requirements

• Bachelor's degree in a scientific or related discipline
• At least 1+ years of direct regulatory experience in the medical device field
• Recent experience with Class III implantable medical devices preferred
• Exposure to authoring and/or supporting PMA supplements and familiarity with EU MDR (2017/745) requirements are desirable
• Working knowledge of FDA PMA guidance documents, 21 CFR regulations, and EU regulatory frameworks