Global QA & Regulatory Field Actions Lead

Leica Biosystems Inc.; Newcastle upon Tyne; On-site; GBP 65,000 - 90,000; Full time

Job summary

Leica Biosystems in the United Kingdom (Newcastle) seeks a Senior Specialist in Quality Assurance and Regulatory Compliance (QARC) to lead global field actions, ensuring compliance with EU IVDR, UK, FDA and Health Canada requirements. This on-site role partners with multiple teams to drive corrective actions and post-market activities.

The role reports to the Director II, Global Quality Management Programs and focuses on governance, risk assessments and continuous improvement within a global

Qualifications

• Experience directly managing field actions including recalls or FSCAs.
• Knowledge of post-market requirements (EU IVDR, UK, FDA, Health Canada).
• Experience interacting with authorities and leading cross-regional activities.

Responsibilities

• Lead and coordinate global field actions from initial assessment to closure with regulatory alignment.
• Serve as global field action process owner and SME for procedures and compliance.
• Collaborate with Quality, Regulatory, Operations and Commercial teams across regions.
• Coordinate regulatory notifications and customer communications; oversee effectiveness checks.
• Drive governance, inspection readiness and continuous improvement with KPI reviews.

Skills

Field actions leadership

Regulatory compliance

Cross-functional collaboration

Risk assessment

Education

Bachelor’s degree in a scientific, medical or technical field

Job description

Leica Biosystems in the United Kingdom (Newcastle) seeks a Senior Specialist in Quality Assurance and Regulatory Compliance (QARC) to lead global field actions, ensuring compliance with EU IVDR, UK, FDA and Health Canada requirements. This on-site role partners with multiple teams to drive corrective actions and post-market activities.

The role reports to the Director II, Global Quality Management Programs and focuses on governance, risk assessments and continuous improvement within a global