What are the responsibilities and job description for the Vice President of Regulatory, Quality & Clinical position at Regulatory Affairs Professionals Society?
Details
Posted : 03-Mar-25
Location : Arden Hills, Minnesota
Type : Full Time
Salary : DOE
Categories :
Quality / Risk Management US Regulatory Affairs
Salary Details :
Base Salary : Market-based, DOEBonus : 30%Equity
Preferred Education :
Masters
Internal Number : 1852
Lead Regulatory, Quality & Clinical Affairs for a Breakthrough Active Implantable Device
Our client, a high-growth, privately held medical device company , is transforming pain management for amputees suffering from chronic post-amputation pain . Their FDA-approved, patient-controlled neuromodulation device provides a non-opioid solution to significantly improve quality of life. As they scale toward commercialization , they seek a strategic and hands-on leader to drive regulatory approvals, quality excellence, and clinical evidence generation.
Key Responsibilities Include :
- Serve as the Management Representative and primary FDA contact for audits, submissions & compliance.
- Lead AIMD regulatory submissions (IDE, PMA, supplements, post-market surveillance).
- Oversee post-market surveillance , including complaint handling, product monitoring, and regulatory reporting.
- Ensure regulatory alignment with clinical strategy for evidence-based approvals.
- Oversee Quality Assurance and QMS compliance (FDA 21 CFR Part 820, ISO 13485).
- Direct clinical trial strategies , ensuring adherence to GCP and regulatory requirements .
- Lead and develop high-performing teams across regulatory, quality & clinical functions.
- Represent the company in regulatory and industry interactions .
What You’ll Need :
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