Quality Systems and Regulatory Compliance Manager

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

Job title: Quality Systems and Regulatory Compliance Manager

Department: QA/RC

Location: Hamble

GLS: M03

Working hours: 37.5, 5 days a week on-site

A brighter future awaits you

CooperVision is one of the world’s leading manufacturers of soft contact lenses with a presence in over 100 countries. Being part of CooperVision means helping improve the way people see each day. It’s more than making contact lenses, it’s about giving lens wearers freedom and confidence to move about their daily lives. We’re all about bright futures – for our people and those who wear our contact lenses.

Job summary – What to expect:

As the Quality Systems and Regulatory Compliance Manager you will ensure that the Quality Management System implemented at UK Manufacturing sites remains compliant to all applicable standards and regulations of a medical device manufacturer. You’ll coordinate and improve Quality System and Regulatory Compliance processes, across all UKM sites (Hamble & Chandler’s Ford), and ensure alignment of process execution across other sites within the Quality Management System (Delta Park, Mountpark and Liège).Some travel will be required between sites.

Your responsibilities will include:

1. Coordinating and improving internal Quality System processes through the following:

   1. Management of Quality Systems Team
   2. Management of the Document Control and eQMS Team
   3. Works with Manufacturing, Operations and CAPA Leaders to ensure that CAPAs are appropriately prioritized.
   4. Tracks Quality System process performance using appropriate measures and KPIs, and reports as appropriate.
   5. Ensure the compliant execution of Quality System processes including CAPA, Internal Audit, Management Review and Document Control.

2. Coordinate and execute Regulatory Compliance activities for all sites covered by the UK Quality Manual, including:

   1. Management of the Regulatory Compliance Team
   2. Leading and coordinating External Audits from Notified Bodies, Customers or other Regulatory organizations.
   3. Supporting the submission of information to Regulatory Affairs personnel to ensure registration of products and facilities.
   4. Ensure communication of Manufacturing Changes to appropriate Regulatory Affairs personnel.

3. Acts as Management Representative for UK Manufacturing sites (Hamble and Chandler’s Ford Campus).

   1. Ensure communication with other Management Representatives for UK Packaging & Distribution and Liege Distribution.
   2. Ensure processes needed for the Quality Management System are documented.
   3. Ensure that the performance of the management system is reported to senior management including any areas of improvement, through established forums.
   4. Ensure that awareness of applicable regulatory requirements and quality management system requirements are communicated throughout the organization.

4. Supports Investigation, Implementation and Effectiveness Review activities for CAPAs, working with CAPA Leaders and other RA/QA team members, and ensuring a consistent approach.

5. Partner with QA colleagues from other facilities, and Global QA Groups to ensure continuous improvement of the UKM QMS, and implementation of preventive actions.

6. Performance of Internal Audits including the development of audit plans and reports, participation in internal audits, communicating audit findings.

7. Leads continuous improvement activities associated with Quality System processes.

A full job description is available upon request.

About you:

We are looking for someone with:

• Ability to influence across functions, with a demonstrated track record of driving global initiatives to successful completion.
• Strong analytical and problem-solving skills, with the ability to interpret data, identify trends, and assess quality and regulatory risk.
• Excellent written and verbal communication skills, with the ability to clearly articulate regulatory expectations, technical concepts, and quality risks to diverse stakeholders.
• Strong organizational and prioritization skills, capable of managing multiple priorities in a fast paced, global environment.
• High attention to detail.
• Ability to work effectively in a multinational and multicultural environment.
• Ability to read and understand technical material.

Experience & Education:

Required:

• 5+ years of experience in the Medical Device or Pharmaceutical industry, within a Quality Assurance, Quality Systems or Regulatory Affairs role.
• Working knowledge of standards and regulations applicable to Medical Devices, including but not limited to ISO 13485, EU MDR 2017/745 and MDSAP.
• Working knowledge of the application of a Quality Management System (QMS) and the use of electronic QMS software to manage quality records, preferably Agile.
• Educated to degree level, in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline, or with suitable relevant quality experience / qualifications.
• Qualified as an ISO 13485 Lead Auditor

What we offer:

You’ll receive competitive compensation and a fantastic benefits package including 25 days holiday, pension scheme, healthcare cover, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!

We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.

We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVision.

What you can expect:

As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering an inclusive culture is and how different perspectives add value and contribute to our success.