Director of Regulatory Affairs & Device Quality Systems

Nephron Pharmaceuticals Corporation; Columbia (SC); On-site; USD 180,000 - 250,000; Full time

Job summary

Nephron Pharmaceuticals Corporation is seeking a Director of Regulatory Affairs and Device Quality Systems to lead regulatory and device-quality activities across manufacturing divisions and affiliated entities.

This role ensures end-to-end regulatory compliance, post-market vigilance, labeling governance, licensing maintenance, and quality-system oversight for medical devices and combination products.

Qualifications

• PharmD/PhD or equivalent with 7+ years in pharma or medical-device industry.
• 5+ years in Regulatory Affairs or Device Quality Systems leadership.
• Experience leading ANDA, 510(k), and 503B submissions.
• Strong technical writing and analytical skills.
• Ability to translate regulatory requirements into business processes.

Responsibilities

• Develop and communicate regulatory and device-quality strategies.
• Lead U.S. and international regulatory strategy for drug, device, and combination-product portfolios.
• Oversee end-to-end regulatory submissions and post-approval activities.
• Serve as liaison to FDA and ensure inspection readiness.
• Oversee device quality systems including design control and CAPA.
• Lead labeling strategy and SPL submissions.
• Provide cross-department regulatory support.
• Mentor regulatory staff and act as SME during inspections.

Skills

Regulatory submissions

FDA/ISO audits

Regulatory writing

Cross-functional leadership

Regulatory strategy

Education

PharmD/PhD or equivalent

Master's/Bachelor's degree

Job description

Nephron Pharmaceuticals Corporation is seeking a Director of Regulatory Affairs and Device Quality Systems to lead regulatory and device-quality activities across manufacturing divisions and affiliated entities.

This role ensures end-to-end regulatory compliance, post-market vigilance, labeling governance, licensing maintenance, and quality-system oversight for medical devices and combination products.