Quality Systems & Regulatory Compliance Lead

CooperVision Limited; Southampton; Hybrid; GBP 70,000 - 90,000; Full time

Benefits offered by this job

25 days holiday

Pension scheme

Healthcare cover

Life assurance

Wellness Platform access

Discounted contact lens scheme

Job summary

CooperVision Limited is hiring a Quality Systems and Regulatory Compliance Manager to oversee the UK Quality Management System, ensuring compliance with medical device standards across Hamble and Chandler’s Ford. You will coordinate Quality and Regulatory teams, manage external audits, and drive CAPA and continuous improvement initiatives.

The role requires leadership across functions and travel between UK sites, with a focus on regulatory submissions, change communications, and maintaining

Qualifications

• 5+ years in Medical Device or Pharmaceutical QA/Quality Systems/Regulatory Affairs
• Experience with ISO 13485, EU MDR 2017/745 and MDSAP
• Knowledge of QMS implementation and electronic QMS systems (preferably Agile)
• Degree in a technical discipline or equivalent quality experience
• Lead Auditor certification (ISO 13485)

Responsibilities

• Coordinate and improve internal Quality System processes across UK sites (Hamble & Chandler’s Ford)
• Lead Regulatory Compliance activities, audits and registrations
• Act as Management Representative for UK Manufacturing sites
• Conduct internal audits and develop audit plans and reports
• Drive continuous improvement of Quality System processes across the organization
• Collaborate with QA colleagues globally to implement preventive actions

Skills

Influence across functions

Analytical skills

Communication skills

Organizational skills

Multinational environment

Education

Bachelor's degree in Engineering / Life Sciences / Chemistry / Biology

ISO 13485 Lead Auditor

Tools

eQMS software

Auditing tools

Job description

CooperVision Limited is hiring a Quality Systems and Regulatory Compliance Manager to oversee the UK Quality Management System, ensuring compliance with medical device standards across Hamble and Chandler’s Ford. You will coordinate Quality and Regulatory teams, manage external audits, and drive CAPA and continuous improvement initiatives.

The role requires leadership across functions and travel between UK sites, with a focus on regulatory submissions, change communications, and maintaining