Jobs

This role is based in Sylmar, CA and requires employees to work on-site.

Potential to extend and/or convert to FTE for right candidate but no guarantee. Onsite strongly preferred but remote option may be available.

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.

Required Qualifications & Experience

• 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.