Strategic Director, Regulatory Affairs & Device Quality
Nephron Pharmaceuticals Corp
Nephron Pharmaceuticals Corporation seeks a Director of Regulatory Affairs and Device Quality Systems to lead regulatory and device-quality activities across manufacturing divisions and affiliates. This role ensures compliance with 21 CFR Part 820, Part 4, ISO 13485, and ISO 14971, while excluding drug-product cGMP quality systems. Responsibilities include strategy development, end-to-end submissions, FDA liaison, and leadership of device quality systems, labeling, pharmacovigilance, and market
#J-18808-LjbffrVacancy posted 3 days ago
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