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Regulatory Consultant

Job description

Title: Part-Time Regulatory Affairs Consultant – Medical Devices (Class II Vascular / Interventional)
Engagement Type: Part-Time Consultant (~20 hours/week)
Location: Irvine, CA (must be local)
Overview
A growing medical device company is seeking a part-time Regulatory Affairs Consultant to support global regulatory activities for Class II vascular and interventional devices. This role will work closely with internal leadership to guide regulatory strategy and execution across U.S., EU, and international markets, supporting product development and commercialization efforts.
Key Responsibilities
  • Support regulatory strategy and submissions for FDA, EU, and other international (OUS) markets.
  • Prepare and manage 510(k), technical documentation, and other regulatory submissions for Class II vascular and interventional devices.
  • Assist with EU MDR documentation and CE Mark activities, including technical files and regulatory compliance.
  • Interface with internal teams including R&D, Quality, and Clinical to ensure alignment on regulatory requirements.
  • Support regulatory communications with agencies and notified bodies as needed.
  • Provide guidance on global regulatory requirements, submission pathways, and timelines.
Qualifications
  • 8+ years of Regulatory Affairs experience in medical devices.
  • Direct experience with Class II vascular, interventional, or cardiovascular devices strongly preferred.
  • Demonstrated experience with FDA submissions (510(k), De Novo) and EU MDR / CE Marking.
  • Experience supporting international/OUS regulatory submissions is highly desirable.
  • Ability to work in a consultative capacity with cross-functional teams.
Engagement Details
  • Approximately 20 hours per week.
  • Flexible schedule; consulting/contract engagement.