Regulatory Compliance Manager
CooperCompanies
Hamble, Hampshire, United Kingdom
1d ago

Description

JOB TITLE Regulatory Compliance Manager

DEPARTMENT Quality Assurance and Regulatory Assurance

LOCATION - Hamble

WORKING HOURS Monday to Friday 08.30am to 4.30pm

What we do every day feels pretty amazing we help improve the way people see each day. It’s about more than making contact lenses, it’s about giving lens wearers freedom and confidence.

And everybody has a part to play in making this happen everybody’s contribution counts, whatever their role or experience.

Which is why at CooperVision, you’ll feel empowered, trusted and supported in everything you do.

What will you be doing :

  • Within the Regulatory Compliance Manager role, you will oversee and improve Regulatory Compliance related processes, including Change Management, Customer Complaints, Risk Management & Document Control;
  • across our Hamble & Chandler’s Ford manufacturing sites. You will provide oversight of all other sites within CooperVision as part of the companies role as legal manufacture.

    You will manage a team of 3 as well as manage second -and third-party audits, including responding to related findings and actions and assume some of the responsibilities of the Person Responsible for Regulatory Compliance, specifically responsibility for the sub clause(s) of Article 15 (3) of the EU Medical Devices Regulation (MDR) 2017 / 745

    Other responsibilities include :

  • Manage the Regulatory Compliance team, while interfacing with the Quality Systems and QA teams supporting Hamble and Chandler’s Ford manufacturing, and Delta Park and Liège packaging & labelling operations.
  • Oversee the change management process, including liaising with Global & Regional RA / QA teams to complete regulatory impact assessments.
  • Be the liaison person with Notified Bodies and other regulatory bodies
  • Plan and coordinate Notified and Regulatory Body audits.
  • Oversee all aspects of the Legal Manufacturer within CooperVision ML
  • Supports third party audits, including Customer & Virtual Manufacturer audits.
  • Manage actions and responses to be taken in relation to regulatory and third party audits.
  • Manage changes and improvements to the quality system to ensure that all facilities remain compliant with applicable current and future standards and regulations.
  • Provide support to design transfer activities as required.
  • Direct the Management Review process, and participation as required in other facility, regional and business management reviews within CooperVision as required.
  • Leads continuous improvement activities associated with Regulatory Compliance processes.
  • What skills and experience should you have?

  • 2-5 years’ experience within Quality Assurance area.
  • Experience of managing people.
  • Knowledge of and experience of regulations for medical devices, including and not limited to ISO Standards MDD MDR MDSAP
  • Internal Audit experience and dealt with external auditors
  • Excellent written and verbal communication skills.
  • Excellent organisational skills.
  • Competent in basic statistical methods (R&R, SPC, 6Sigma)
  • Computer literate, with intermediate skills in the use of Word, Excel and Outlook, and knowledge of relational database systems.
  • What we offer

    You’ll receive competitive compensation and a fantastic benefits package including : 25 days holiday, 10% bonus incentive, pension scheme, Private Medical, healthcare cover, life assurance, a discounted contact lens scheme and much more!

    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.

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