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Senior Regulatory Specialist

Senior Regulatory Specialist

TRICARDIAMaple Grove, MN, United States
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Senior Regulatory Specialist – Onsite : Maple Grove, MN

Medical Device - Interventional Cardiology - Structural Heart

I’m working with a fast growing structural heart medical device company to help them hire a Senior Regulatory Specialist in Maple Grove, MN.

This role will take ownership of global regulatory submissions and technical documentation to support IDE, PMA, and EU MDR filings, working closely with R&D, Quality & Clinical Affairs. It’s a great opportunity for someone who enjoys both the detail of regulatory work and being part of a fast-paced, innovative environment.

Key Responsibilities

  • Review and finalize engineering test reports and technical deliverables to support FDA, EU MDR, and other global submissions.
  • Prepare and support U.S. and international regulatory submissions (IDE, PMA, 510(k), EU MDR, Health Canada, Japan Shonin, etc.).
  • Collaborate with engineering and subject matter experts to address regulatory questions and respond to agency inquiries.
  • Maintain current knowledge of global medical device regulations and ensure compliance.
  • Review labeling, documentation changes, and marketing materials for regulatory accuracy.
  • Assess product and manufacturing changes for regulatory impact and manage required documentation or approvals.

Qualifications

  • Bachelor’s degree in Engineering or related field.
  • Minimum 3 years of regulatory affairs experience in the medical device industry.
  • Experience with FDA submissions (IDE, PMA, 510(k)) and international pathways (EU MDR, Health Canada, Japan Shonin) preferred.
  • Strong writing, editing, and analytical skills with attention to detail.
  • Proficiency in Microsoft Office and regulatory document tools.
  • Highly organized with the ability to manage multiple projects.
  • Willingness to travel up to 10%.
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    Regulatory Specialist • Maple Grove, MN, United States