Regulatory Affairs Manager

Regulatory Affairs Manager (Hybrid Preferred) Location: Irvine, CA | Full-time | Medical Device Industry Join a passionate, mission-driven team dedicated to advancing medical device innovation and improving patient outcomes. As a Regulatory Affairs Manager , you will play a key role in coordinating and preparing regulatory submissions, partnering with cross-functional teams, and ensuring compliance with global regulatory standards. This role offers the opportunity to apply your expertise in a collaborative environment while directly contributing to life-saving technologies. What You’ll Do Develop and implement complex, global regulatory strategies for new and modified devices. Prepare, review, and submit regulatory documentation for the U.S. and international markets. Serve as the regulatory representative on multi-disciplinary project teams, aligning regulatory strategy with business objectives. Interact with FDA, Notified Bodies, and international authorities throughout the device lifecycle. Review product changes, labeling, advertising, and promotion for compliance with applicable regulations. Support ongoing product maintenance, license renewals, and annual registrations. Provide regulatory guidance during audits, inspections, and SOP development. Consolidate and maintain communication with regulatory agencies and cross-functional stakeholders. What We’re Looking For Bachelor’s degree in a scientific, technical, or related field (advanced degree preferred). 5–8 years of regulatory affairs experience in the medical device industry, preferably with Neurovascular or Cardiovascular Devices Hands-on experience with U.S. and EU submissions, including HDE, IDE, and PMA applications . Strong background in writing, project management, and regulatory coordination. Proven experience interfacing with regulatory authorities through all stages of the product lifecycle. Ability to thrive in a fast-paced, deadline-driven environment with cross-functional collaboration. Proficiency with MS Office and Adobe Acrobat.

Created: 2025-10-05