Regulatory Affairs Associate

Title: Regulatory Affairs Associate Location: Sylmar, CA Duration: 7 Months 100% Onsite Summary: 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. Consultants Eligible Benefits Upon Waiting Period: Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account (for High-Deductible Health Plans) Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) Supplemental Life Insurance Short Term Disability (coverage varies by state) Long Term Disability Critical Illness, Hospital coverage, Accident Insurance MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance 401(k) #J-18808-Ljbffr