Regulatory Affairs - Class III
Regulatory Affairs Specialist - Class III exp Location: Moorpark, CA (Remote) Contract: 1+ year assignment Summary: The Regulatory Affairs Specialist will prepare, coordinate, and maintain documentation to support regulatory submissions and Notices of Change for Class III medical devices. This role involves collaboration with internal teams and regulatory agencies to ensure compliance with global regulations and standards. Key Responsibilities: • Prepare and manage regulatory submissions, renewals, and annual registrations. • Support EU MDR and AIMDD technical documentation requirements. • Ensure compliance with ISO 13485 design controls and change management. • Collaborate with Notified Bodies and Competent Authorities. • Recommend and implement labeling, manufacturing, or process changes for regulatory compliance. • Maintain and improve regulatory tracking and control systems. Qualifications: • Bachelor’s degree required. • 3–5 years of regulatory affairs experience (medical device industry preferred). • Experience with EU MDR, AIMDD, and ISO 13485. • Class III medical device and new product development experience preferred. • Strong communication and document management skills. Additional Details: • Remote position. • Applicants must be legally authorized to work in the United States. • Sponsorship, C2C (corp-to-corp), and third-party candidates will not be considered. Apply tot his job