Regulatory Affairs Associate

Responsibilities

• Authoring and submitting U.S. PMA supplements (30-day Notices, Real-Time Reviews, 180-Day Supplements, Annual Reports)
• 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

Requirements

• 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 and familiarity with EU MDR (2017/745) requirements are desirable
• Working knowledge of FDA PMA guidance documents, 21 CFR regulations, and EU regulatory frameworks