Regulatory Affairs Specialist

Job Summary

To support regulatory compliance efforts, the contract Regulatory Affairs Specialist will manage the filing of regulatory applications and interactions with U.S. and international authorities while authoring PMA supplements and updating EU MDR documentation.

Key responsibilities

• File regulatory applications and support communications with regulatory authorities for medical devices
• Author and submit U.S. PMA supplements and assist with EU MDR Technical Documentation updates
• Review and approve engineering study protocols and assess regulatory impacts of manufacturing and design changes

Required qualifications

• 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
• Familiarity with FDA PMA guidance documents and 21 CFR regulations
• Exposure to EU MDR (2017/745) requirements is desirable