Global Field Action Lead - QA & Regulatory

Danaher Corporation; Newcastle upon Tyne; On-site; GBP 65,000 - 95,000; Full time

Job summary

Leica Biosystems in Newcastle, UK, seeks a Senior Specialist, Quality Assurance and Regulatory Compliance (QARC) to lead global field action management. You will coordinate recalls, FSCAs, removals, and related post‑market activities, ensuring regulatory alignment across regions.

As the process owner and SME, you’ll drive compliant execution, support inspection readiness, and enable continuous improvement with cross‑functional teams in a truly global setting.

Qualifications

• Bachelor’s degree in a scientific, medical or technical field is required.
• Experience directly managing field actions, including recalls, FSCAs, corrections or removals within the medical device or IVD industry.
• Knowledge of EU IVDR, UK, FDA and Health Canada requirements and ISO 13485.

Responsibilities

• Lead and coordinate global field actions from initial assessment through implementation, verification and closure.
• Serve as global field action process owner and SME, maintaining procedures and alignment with regulatory requirements.
• Collaborate with Quality, Regulatory, Operations and Commercial teams to assess and escalate field actions.
• Coordinate field action strategy and execution, including regulatory notifications and customer communications.
• Lead governance, inspection readiness and continuous improvement with KPI monitoring and cross‑regional sharing.

Skills

Field action management

Regulatory knowledge

Cross-functional collaboration

Quality assurance experience

Education

Bachelor’s degree in scientific/medical/technical field

Job description

Leica Biosystems in Newcastle, UK, seeks a Senior Specialist, Quality Assurance and Regulatory Compliance (QARC) to lead global field action management. You will coordinate recalls, FSCAs, removals, and related post‑market activities, ensuring regulatory alignment across regions.

As the process owner and SME, you’ll drive compliant execution, support inspection readiness, and enable continuous improvement with cross‑functional teams in a truly global setting.