Senior Director, Quality Assurance & Regulatory Compliance

About the role

We are seeking a strategic leader to head the Quality Assurance and Regulatory Compliance function for a global cancer diagnostics organization. This senior position will shape quality and regulatory strategy across a portfolio of advanced diagnostic and companion diagnostic products, driving innovation while ensuring compliance with stringent regulatory standards.

Key responsibilities

• Develop and execute global quality and compliance strategies aligned with business growth and product innovation.
• Partner with senior leaders in Regulatory Affairs, Clinical Affairs, Medical Affairs, and Operations to integrate quality objectives.
• Oversee quality systems, product quality, issue resolution, and regulatory compliance activities worldwide.
• Lead continuous‑improvement initiatives, process optimisation, and KPI tracking across sites.
• Manage departmental budgets, resources, timelines, and organisational priorities.
• Build, mentor, and develop a high‑performing quality team, fostering a culture of accountability and innovation.

Required profile

• 15+ years of progressive experience in Quality Assurance and Regulatory Compliance within the medical‑device or diagnostics industry.
• Proven track record of leading global quality organisations and delivering regulatory approvals.
• Strong business acumen with the ability to align quality initiatives with commercial objectives.
• Excellent leadership, communication, and stakeholder‑management skills.

Required skills

• Quality Management Systems (QMS) implementation and maintenance
• Regulatory compliance (e.g., ISO 13485, FDA 21 CFR Part 820)
• KPI development and performance monitoring
• Budget and resource planning

What we offer

• Opportunity to influence the quality strategy of a leading cancer‑diagnostics company
• Competitive executive compensation package
• Global exposure and collaboration with cross‑functional senior leaders
• Relocation support for the right candidate