Regulatory Affairs Associate

Overview

• Job Title :
  Regulatory Affairs Associate
• Duration : 12 months with possible extension
• Location :
  San Clemente, CA/HYBRID
• Schedule :
  Monday to Friday, 8.00AM to 5.00PM
• Job Description :
  Regulatory Affairs Associate– Medical Devices

We are seeking a Regulatory Affairs Associate to support U.S. and global regulatory submissions for medical device products. This role will assist in executing global regulatory strategies, preparing and maintaining registration dossiers, and ensuring compliance with FDA, EU, and international regulatory requirements.

• Prepare and manage U.S. and global regulatory submissions, including FDA and CE technical documentation
• Support execution of global regulatory strategies with oversight
• Track regulatory deliverables and ensure timely, accurate submissions
• Review technical and quality documentation for regulatory compliance
• Collaborate with R&D and global/regional RA partners to assess regulatory impact of changes
• Respond to regulatory agency and notified body inquiries under supervision
• Represent Regulatory Affairs on project and product teams

• Bachelor’s Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• 2–4 years of Regulatory Affairs experience in the medical device industry
• Strong knowledge of FDA, EU, and global submission requirements
• Hands-on experience with FDA submissions and CE technical documentation
• Working knowledge of 21 CFR 820 and ISO 13485:2016
• Strong analytical, communication, and problem-solving skills