Regulatory Affairs Associate

Location

San Clemente, CA and San Diego, CA

Regulatory Affairs Associate II responsible for providing regulatory support for U.S. and global medical device submissions. The role supports execution of global regulatory strategies, preparation and maintenance of registration dossiers, and ensures regulatory compliance for product approvals and change management activities. The associate works cross-functionally with R&D and regional regulatory teams and supports interactions with regulatory authorities and notified bodies under supervision.

• Strong knowledge of FDA, EU MDR, and global regulatory submission requirements
• Experience preparing FDA submissions and CE technical documentation
• Experience preparing Technical Files / Technical Documentation
• Experience with 510(k) and ISO 13485
• Understanding of 21 CFR 820 and ISO 13485:2016
• Ability to assemble and maintain global regulatory dossiers
• Strong documentation review and technical writing skills
• Critical thinking and scientific assessment capability
• Strong organizational and project-tracking skills
• Effective written and verbal communication
• Ability to manage multiple deadlines and priorities

• 2–4 years of Regulatory Affairs experience in the medical device industry
• Hands-on experience with FDA and international regulatory submissions
• Experience authoring or supporting CE Technical Files
• Exposure to working with regulatory agencies or notified bodies preferred

• Preferred fields:
  Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or related scientific discipline
• RAC certification preferred but not required.