Code of Federal Regulations, FDA (Food and Drug Administration), Follow Through, Implants, Manufacturing, Medical Equipment, Regulations, Regulatory Submissions, Research Protocols, Technical Writing, Validation Plan
LOCATION
Sylmar, CA
POSTED
1 day ago
Job Title - Regulatory Affairs Associate
Duration: 6+ months of contract role (Potential to extend and/or convert to FTE for the right candidate)
Location: 15900 Valley View Court, Sylmar, CA 91342 (Onsite role)
Shift - 8 am to 5 pm
Job 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.
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.