Senior Regulatory Specialist

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