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Head of Quality and Regulatory Medical Devices, ISO13485, QARA

SJB Technical Ltd
Job LocationCardiff
EducationNot Mentioned
Salary£45,000 - £65,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Head of Quality and Regulatory Medical Devices, ISO13485, QARACardiffSalary c£65k My client is a growing medical devices company with an innovative product that is making a significant contribution to improvements in surgical proceduresAs they further develop their products and systems, they are now seeking a Medical Devices Head of Quality Assurance and Regulatory Affairs responsible for managing all the company’s quality management and regulatory activities and to support the company in meeting its quality objectives and to meet the requirements of the Medical Device Regulations and for product registration in other countries with a hands-on, flexible approach for the differing regulatory needs around the world.Duties and responsibilities:

  • To be the company’s appointed Manager for quality and regulatory affairs.
  • Continue the establishment, implementation and maintenance of a quality management system to be compliant with ISO13485
  • Support ongoing development of the technical files and clinical evaluations report updates
  • Apply for regulatory approval in target markets
  • Assist with the company’s regulatory strategy for its current and future products
    • Essential Skills:
  • At least 5 years’ experience and a proven track record with regulatory and quality assurance
  • Prior experience leading the establishment, implementation and maintenance of a quality management system in accordance with the ISO13485
  • Structured and methodical problem solving
  • Team player who is comfortable working as part of a close-knit project team
  • Good reporting and presentation skills

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