Regulatory Affairs Associate

Responsibilities 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. Qualifications 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. Additional Information 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. This role is based in Sylmar, CA and requires employees to work on-site. Pay ranges between 30-40/hr based on experience. #J-18808-Ljbffr Planet Pharma