Company Overview:

About Function & Ezra

Our Mission at Ezra

Role:

As a Regulatory Affairs Specialist at Ezra, you will:

• Execute post-market surveillance activities and maintain ongoing compliance for our SaMD products across multiple jurisdictions
• Support regulatory submissions by preparing, compiling, and coordinating applications for FDA, CE Mark, and other global medical device approvals
• Conduct regulatory assessments for new products, product enhancements, and changes to existing devices
• Review and provide regulatory input on labeling, instructions for use, and technical documentation
• Maintain global product registrations, facility listings, and establishment registrations
• Contribute to the development of regulatory strategy and stay current on evolving SaMD regulations
• Liaise with regulatory bodies and respond to regulatory inquiries
• Provide input on Quality Risk Management activities
• Assist in post-market compliance activities including CAPA investigations, complaint handling, and internal audits
• Provide input on Quality Risk Management, Product Design and Development Risk Management activities
• Help ensure procedures enable operations and engineering teams to work efficiently within regulatory requirements
• Assist with external audits and regulatory inspections as needed

Key Responsibilities:

Requirements:

• 3+ years of hands-on regulatory affairs experience with medical devices, preferably including SaMD
• 3+ years working with quality standards: 21 CFR Part 820, ISO 13485:2016, and MDSAP
• Global product submissions experience
• ML experience for submissions. Familiarity with AI/ML-enabled medical devices and their unique regulatory considerations
• Proven experience in regulated software development environments (medical device, pharma, aviation, or nuclear)
• Experience developing regulatory strategies specifically for SaMD products
• Strong understanding of risk-based decision making and quality risk management principles
• Excellent cross-functional collaboration and communication skills
• Detail-oriented with the ability to manage multiple priorities in a fast-paced startup environment

• RAPS Regulatory Affairs Certification (RAC) or ASQ Certified Quality Auditor (CQA)

To be a strong fit, you embody our Core Values:

• Ruthless Prioritization:
  • We don’t let perfect get in the way of progress.
  • We move quickly to drive value, not perfection.
  • We prioritize what drives impact.
  • We never compromise on standards of excellence.
• Member-First, Always:
  • We design and deliver like we’re caring for someone we love.
  • We create clear, actionable, human experiences.
  • We prioritize responsiveness, peace of mind, and outcomes.
  • We empower members with truth, clarity, and care.
• One Team, Moving Fast:
  • We are aligned in purpose, prioritization, and speed.
  • We gather diverse perspectives to make informed decisions.
  • We clear paths for each other and move fast together.
  • We communicate clearly and respectfully, rallying around shared goals.
• Radical Ownership, Relentless Execution:
  • We don’t just ship—we own outcomes and drive results.
  • We act with urgency and precision.
  • We anticipate, initiate, and follow through.
  • We meet challenges with grit and pragmatism.
  • We embrace new tech to deliver better outcomes.
• Mission Over Ego:
  • We are ruthlessly aligned to our mission—and leave ego at the door.
  • We disagree and commit.
  • We don't tolerate politics or withholding information.
  • We operate with honesty, transparency, and respect.
• Sustained Integrity in Every Detail:
  • We earn trust by obsessing over accuracy, quality, and clarity in everything we do.
  • We prioritize clinical precision—data must be right.
  • We sweat the details because outcomes depend on them.

Why You'll Love Working With Us: