Job Description

Job Title : Regulatory Affairs Associate

Location : Santa Clara, CA

Duration : 12 Months

Schedule : 8:00 AM 5:00 PM

Position Overview

The Regulatory Affairs Associate will be responsible for supporting regulatory strategy, submissions, and compliance activities for Class III implantable medical devices. This role requires strong expertise in FDA regulatory pathways, labeling requirements, and PMA supplement submissions. The candidate will work cross-functionally with engineering, quality, and manufacturing teams to ensure regulatory compliance throughout the product lifecycle.

Key Responsibilities

• Author, review, and submit PMA supplements, including:
  • 30-Day Notices
  • Real-Time Reviews
  • 180-Day Supplements
  • Annual Reports
• Manage and execute regulatory labeling activities, including addendum and supplemental labeling updates
• Review and approve:
  • Engineering study protocols and reports
  • Validation study protocols and reports
  • Manufacturing changes for Class III implantable devices

• Ensure compliance with FDA PMA guidance documents and CFR regulations
• Serve as a liaison for regulatory authority interactions, including submission handling and follow-ups
• Collaborate with cross-functional teams to support product development and change management
• Provide regulatory guidance and may lead or direct the work of junior team members

Required Qualifications

• Minimum 5+ years of experience in Regulatory Affairs
• Strong experience with Class III implantable medical devices
• Proven track record of successful PMA supplement authoring, submission, and approvals
• Hands-on experience with regulatory labeling (addendum, supplemental, and change execution)
• Solid understanding of FDA regulations and medical device quality systems
• Ability to manage multiple projects with a high degree of autonomy and judgment

Preferred Skills

• Experience working in a highly regulated medical device environment
• Strong analytical, documentation, and communication skills
• Ability to work independently and lead cross-functional initiatives

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