Quality Systems and Regulatory Compliance Manager

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:

Coordinating and improving internal Quality System processes through the following: Management of Quality Systems Team Management of the Document Control and eQMS Team Works with Manufacturing, Operations and CAPA Leaders to ensure that CAPAs are appropriately prioritized. Tracks Quality System process performance using appropriate measures and KPIs, and reports as appropriate. Ensure the compliant execution of Quality System processes including CAPA, Internal Audit, Management Review and Document Control.

Management of Quality Systems Team

Management of the Document Control and eQMS Team

Works with Manufacturing, Operations and CAPA Leaders to ensure that CAPAs are appropriately prioritized.

Tracks Quality System process performance using appropriate measures and KPIs, and reports as appropriate.

Ensure the compliant execution of Quality System processes including CAPA, Internal Audit, Management Review and Document Control.

Coordinate and execute Regulatory Compliance activities for all sites covered by the UK Quality Manual, including: Management of the Regulatory Compliance Team Leading and coordinating External Audits from Notified Bodies, Customers or other Regulatory organizations. Supporting the submission of information to Regulatory Affairs personnel to ensure registration of products and facilities. Ensure communication of Manufacturing Changes to appropriate Regulatory Affairs personnel.

Management of the Regulatory Compliance Team

Leading and coordinating External Audits from Notified Bodies, Customers or other Regulatory organizations.

Supporting the submission of information to Regulatory Affairs personnel to ensure registration of products and facilities.

Ensure communication of Manufacturing Changes to appropriate Regulatory Affairs personnel.

Acts as Management Representative for UK Manufacturing sites (Hamble and Chandler’s Ford Campus). Ensure communication with other Management Representatives for UK Packaging & Distribution and Liege Distribution. Ensure processes needed for the Quality Management System are documented. Ensure that the performance of the management system is reported to senior management including any areas of improvement, through established forums. Ensure that awareness of applicable regulatory requirements and quality management system requirements are communicated throughout the organization.

Ensure communication with other Management Representatives for UK Packaging & Distribution and Liege Distribution.

Ensure processes needed for the Quality Management System are documented.

Ensure that the performance of the management system is reported to senior management including any areas of improvement, through established forums.

Ensure that awareness of applicable regulatory requirements and quality management system requirements are communicated throughout the organization.

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

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

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

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.

If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.

Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities.

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