Regulatory Affairs Associate

Regulatory Affairs Associate

This role is based in Sylmar, CA and requires employees to work on-site. 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. Requires a bachelor's degree in a scientific or related discipline and 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. Relies on experience and judgment to plan and accomplish assigned goals. Performs a variety of tasks with guidance as needed. Demonstrates accountability for deliverables and ability to follow through on submissions and regulatory activities. A moderate degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.