Posted on 15 Jan 2026

Director, Clinical & Regulatory Affairs

Remote
Permanent
$180,000 - $220,000

About The Company

A fast-growing, global medical device organization with multiple commercial products and a robust pipeline, focused on advancing innovative solutions in cardiovascular and vascular care. 

Responsibilities 

  • Lead global clinical and regulatory strategy across a multi-product portfolio
  • Oversee clinical trials, registries, and post-market evidence generation
  • Direct US and international regulatory submissions (FDA, CE, global markets)
  • Act as primary liaison with regulatory authorities and notified bodies
  • Ensure alignment between clinical evidence, regulatory approvals, and commercial goals
  • Oversee CROs, investigators, and external partners
  • Drive post-market surveillance, vigilance, and clinical compliance activities
  • Build and lead high-performing clinical and regulatory teams

Qualifications 

  • 12+ years' experience in Clinical Affairs and/or Regulatory Affairs within medical devices
  • Proven leadership of clinical trials and global regulatory submissions
  • Strong experience with FDA Class II/III and international pathways
  • Demonstrated success interfacing with regulators and leading inspections
  • Strategic, executive-level communicator with strong cross functional leadership skills

Why You Should Apply

  • True leadership role shaping global clinical and regulatory strategy
  • Influence across commercialized products and next-generation pipeline
  • Competitive compensation with flexibility for top-tier candidates
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