Global Field Actions QA & Regulatory Lead

Radiometer; Newcastle upon Tyne; On-site; GBP 70,000 - 95,000; Full time

Job summary

Leica Biosystems, a Danaher company, is seeking a Senior Specialist for Quality Assurance and Regulatory Compliance (QARC) to lead global field actions from initial assessment through implementation and closure. The role supports inspection readiness and continuous improvement within the Global Quality Organization, located on-site in Newcastle, UK.

Key responsibilities include aligning with EU IVDR, UK, FDA, Health Canada, and ISO 13485 requirements, and partnering with Quality, Regulatory,

Qualifications

• Experience directly managing field actions (recalls, FSCAs, corrections/removals) in medical device/IVD.
• Knowledge of post‑market requirements and regulatory authorities (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 through implementation and closure.
• Maintain global procedures and align with regulatory requirements across regions.
• Support inspection readiness and continuous improvement through KPI monitoring and cross‑regional sharing.
• Collaborate with Quality, Regulatory, Operations and Commercial teams to assess and elevate field action strategies.

Skills

Field action management

Regulatory compliance

Cross-functional collaboration

Inspection readiness

Education

Bachelor’s degree in scientific/medical/technical field

Job description

Leica Biosystems, a Danaher company, is seeking a Senior Specialist for Quality Assurance and Regulatory Compliance (QARC) to lead global field actions from initial assessment through implementation and closure. The role supports inspection readiness and continuous improvement within the Global Quality Organization, located on-site in Newcastle, UK.

Key responsibilities include aligning with EU IVDR, UK, FDA, Health Canada, and ISO 13485 requirements, and partnering with Quality, Regulatory,