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Director of Quality/Regulatory

recruit121
Job LocationCardiff
EducationNot Mentioned
Salary£70,000 - £100,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Are you passionate about driving change in a business where Quality is the key to the businessThis is a great opportunity for a Director of Quality/Regulatory to join a business as it enters an exciting period.A Director of Quality/Regulatory is required for a world class medical device manufacturer in the South West of the UK with a £70M + turnover.As a Director, you will work with the senior management team to ensure Global compliance with the legal requirements for all medical devices regulations; operating at a strategic level to ensure stringent quality requirements are met.Duties include: -

  • Be the main interface with all authorities regarding product manufacture and compliance with MDR
  • Ensure that all product conforms to the required standards -
  • Work with your managers to establish and maintain the CE documentation to ensure that the products manufactured meet with the legislation in force -
  • Provide strategic advice on packaging and labelling requirements, ensuring compliance with the directives -
  • Control all CE device requirements for manufactured products
  • Development of the ISO13485 management system
  • Co-operate closely with the Technical Director and team, to ensure product development and process management align to effectively bring new products to market within required time lines and ensure legacy product management is efficiently maintained.
  • Develop, manage and motivate your teams.
    • We are interested in speaking to candidates with the following skill set: -
  • Proven experience in a Quality or Regulatory role in medical devices at management, director or ""head of"" level in a medical device manufacturing business with a strong understanding of regulatory compliance -
  • Extensive European Medical Device Regulation (MDR) experience -
  • MUST have Class III Medical devices experience - 13485 management experience - Degree in either Chemistry or Biology -
  • Professional, enthusiastic personality -
  • Proven track record of people development
    • We offer a class leading package for the right person so if you match the specified criteria and are interested in discussing the position in more detail, we would love to hear from you. Required skills
  • Medical Devices
  • Regulatory Requirements
  • ISO Procedures
  • MDR
  • CE marking

    • Keyskills :
    Medical Devices Regulaty Requirements ISO Procedures MDR CE marking

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