Head of Quality & Regulatory – Clinical Tech

Unio Search; United States; On-site; USD 150,000 - 230,000; Full time

Job summary

Unio Search is exclusively retained by a growing digital health / clinical technology company to appoint a Director of Quality & Compliance. This is not a traditional corporate QA role; you will own the established QMS and serve as the senior day-to-day quality leader, partnering with executive leadership and teams across Clinical Operations, Product, Software Quality, Security and Client Services.

The role focuses on proactive, scalable quality, with ownership of Enterprise QMS leadership,

Qualifications

• 8+ years in Quality, Compliance or Quality Systems.
• Strong GCP / clinical research Quality experience.
• QMS, CAPA, audit and inspection experience.
• Exposure to 21 CFR Part 11 / ISO 13485 considerations.

Responsibilities

• Lead enterprise QMS leadership and continuous improvement.
• Sponsor and prepare for audits, certifications and inspections.
• Oversee CAPAs, deviations, investigations, and internal audits.
• Develop SOPs, training and management review cadence.
• Drive quality metrics, risk management and process improvements.
• Ensure compliance across GCP, 21 CFR Part 11 and medical-device expectations.

Skills

Quality leadership

Audit readiness

Regulatory affairs

Job description

Unio Search is exclusively retained by a growing digital health / clinical technology company to appoint a Director of Quality & Compliance. This is not a traditional corporate QA role; you will own the established QMS and serve as the senior day-to-day quality leader, partnering with executive leadership and teams across Clinical Operations, Product, Software Quality, Security and Client Services.

The role focuses on proactive, scalable quality, with ownership of Enterprise QMS leadership,