Regulatory Affairs Associate

Position Title: Regulatory Affairs Associate

Work Location: Sylmar, CA 91342

Assignment Duration: 6 Months

Work Schedule: 8:00 AM - 5:00 PM

Work Arrangement: Onsite

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.

• 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).
• Supporting EU MDR Technical Documentation updates.
• Supporting change assessments.
• Supporting Notified Body submissions.
• Review/approval of engineering study protocols/reports.
• Review/approval of validation study protocols/reports.
• Review and approval of manufacturing and design changes for Class III implantable medical devices.
• Assessment of regulatory impact under both FDA and EU MDR requirements.

• Requires a 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.
• Familiarity with EU MDR (2017/745) requirements.
• Working knowledge of FDA PMA guidance documents.
• Working knowledge of 21 CFR regulations.
• Working knowledge of 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.