Strategic Director, Regulatory Affairs & Device Quality

Nephron Pharmaceuticals Corporation; West Columbia (SC); Hybrid; USD 180.000 - 250.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 7+ years in pharmaceutical or medical-device industry with regulatory affairs/quality leadership.
• Experience leading ANDA, 510(k), and 503B submissions is required.
• Strong knowledge of QMSR (21 CFR Part 4) and ISO 13485/14971.

Aufgaben

• Direct regulatory and device-quality strategies aligned with corporate goals.
• Oversee end-to-end regulatory submissions for drug, device, and combination products.
• Serve as liaison to FDA and other health authorities; ensure inspection readiness.
• Lead device quality systems including design control, CAPA, and risk management.
• Oversee labeling strategy and SPL submissions across multiple product types.

Kenntnisse

Regulatory strategy

Leadership

Regulatory submissions

Quality systems

Risk management

Cross-functional leadership

Ausbildung

PharmD/PhD or equivalent

MS/BS degree

Jobbeschreibung

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