Director, Regulatory Affairs & Device Quality

NEPHRON SC, LLC; West Columbia (SC); Hybrid; USD 180,000 - 240,000; Full time

Job summary

NEPHRON SC, LLC is seeking a Director of Regulatory Affairs and Device Quality Systems to provide strategic and operational leadership for regulatory and device-quality activities across manufacturing divisions.

The role ensures end-to-end regulatory compliance, post-market vigilance, labeling governance, and quality-system oversight for medical devices and combination products, including FDA and global obligations.

Qualifications

• Proven experience leading ANDA, 510(k), and 503B submissions.
• Comprehensive understanding of 21 CFR Part 4, 210/211, 820, ISO 13485, and 14971.
• Strong technical writing, analytical, and root-cause-investigation skills.
• Ability to translate regulatory requirements into actionable business processes and procedures.
• Leadership presence with cross-functional influence and executive stakeholder engagement.
• Excellent organization and decision-making in fast-paced environments.

Responsibilities

• Develop and communicate regulatory and device-quality strategies aligned with corporate objectives.
• Lead U.S. and international regulatory strategy for drug, device, and combination-product portfolios.
• Oversee end-to-end regulatory submissions and dossiers, including ANDA, 510(k), and 503B filings.
• Serve as liaison to FDA and other health authorities, ensuring inspection readiness.
• Direct regulatory risk assessments, change-control impact evaluations, and market-action decisions.
• Oversee device quality systems including design control, CAPA, and complaint investigations.
• Lead labeling strategy and regulatory governance across product lines.
• Direct pharmacovigilance and post-market safety activities per FDA requirements.

Skills

Regulatory strategy

FDA liaison

QMSR compliance

ISO 13485

21 CFR 820

Leadership

Regulatory submissions

Education

PharmD/PhD/Equivalent

Master/Bachelor in related field

Job description

NEPHRON SC, LLC is seeking a Director of Regulatory Affairs and Device Quality Systems to provide strategic and operational leadership for regulatory and device-quality activities across manufacturing divisions.

The role ensures end-to-end regulatory compliance, post-market vigilance, labeling governance, and quality-system oversight for medical devices and combination products, including FDA and global obligations.