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Quality and Regulatory Manager

Sigma Recruitment Ltd
Job LocationCathays Park
EducationNot Mentioned
Salary£65,000 - £75,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Opportunity for a quality and regulatory manager to work with a company that is a global leader for their particular specialism in their field. They are currently looking to bring new technology to their marketplace and are expanding their team to aid this, while also having a portfolio of additional ideas and technologies to develop in the future.You will work closely with the managing director and other senior members of the team. The head of quality will be the representative for all quality and regulatory affairs matters for the company managing the quality management system.As the quality and regulatory manager your duties will include:

  • Overall responsibility for the implementation and maintenance of the company QMS
  • Establishing, implementing and maintaining processes needed for the company QMS
  • Promoting the awareness of regulatory and customer requirements throughout the organisation
  • Liaison with external parties on matters relating to the QMS
  • Compilation of technical files and regulatory submissions
  • Compliance overview for design and development projects
  • Defining quality requirements for external suppliers and ensuring that these are met
    • To apply for the quality and regulatory manager role, you will need:
  • Previous experience of working in the medical device field
  • Experience with a range of standards and systems such as ISO:13485, 21 CFR 820, ISO:14971, etc.
  • Experience with external directives such as MDD, MDR, etc.
  • Exposure to dealing with the FDA and CE Marking
  • Strong statistical data analysis skills
    • In return, the quality and regulatory manager will receive a salary of £65,000-£75,000 (dependent on experience - possibly more for the right candidate) + pension, private medical, potential annual bonus, etc.If you are a Quality and Regulatory Manager, QA Manager, Regulatory Affairs Manager, Head of Quality, Head of QA and RA, Quality Director, etc. who wishes to be considered for the role, please click on the apply button.By applying youre giving consent for the Sigma Recruitment agency in Cardiff, to contact you regarding this job and other vacancies were recruiting for. Required skills
  • Regulatory Affairs Manager
  • Head of Quality
  • Quality Director
  • ads@sigmarecruitment.co.uk
  • Quality and Regulatory Manager
  • engineering recruitment agencies
  • Head of QA & RA
  • Head of QA and RA

    • Keyskills :
    Regulaty Affairs Manager Head of Quality Quality Direct adssigmarecruitment.co.uk Quality and Regulaty Manager engineering recruitment agencies Head of QA RA Head of QA and RA

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