Regulatory Affairs Associate

Job Title:

Regulatory Affairs Associate Duration: 12 months with possible extension

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 (science/engineering preferred)
• Direct medical device regulatory experience (NOT pharma/biotech only)
• Hands‑on regulatory submissions experience
• Experience interacting with FDA and/or Notified Bodies
• Experience preparing Technical Files / Technical Documentation
• Recent EU MDR experience, including one or more of the following:
• 017/745, GSPR, EU MDR remediation/compliance for Medical Device