Recruitment

Recruitment

  • We recognise that the success of our company depends on maintaining the highest standards of business conduct, integrity, safety, quality and respect for our people and the environment in everything we do. We have a highly qualified team dedicated to satisfying our customers’ needs.
  • Our employment policy ensures that we have the right professional people to provide an efficient and effective service to our customers.
  • Our sales team have a thorough understanding of the certification market and are committed to achieving customer satisfaction.
  • If you are an honest, responsible and hard-working person with qualifications appropriate to the relevant position, we would be glad to work with you.
  • Current Vacancies:

Person Responsible for Regulatory Compliance (PRRC) for MDR 2017/745

Work Location: EU

Main responsibilities:

  • Conformity of the product device to the Medical Device Regulation and Quality Management System to ISO 13485
  • Conformity of the Technical Documentation and EU Declaration of conformity
  • Compliance with Post-Market Surveillance (PMS) following Article 10(10)
  • Compliance with the Vigilance Reporting obligations (Article 87 to 91)
  • For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)

Education and Work Experience Requirements:

  • Higher education diploma in medicine, pharmacy, or another scientific discipline (medicine and pharmacy diploma holders will be given preference) and at least 2 years of experience in Regulatory Affairs or Quality Management System on medical devices.
  • Candidates without relevant higher education diploma can be considered if at 4 years of related experience in Regulatory Affairs or Quality Management System on medical devices. Preference will be given to candidates with relevant experience in the following fields:
    • • Medical device testing and/or inspection;
    • • Medical product design;
    • • Clinical evaluation;
    • • Quality management assessment in the medical industry, e.g. assessment to ISO 13485, GMP assessment.

Medical Devices Technical Expert

Work Location: UK

Main responsibilities:

  • Conformity of the product device to the UK MDR 2002 Regulation and Quality Management System to ISO 13485
  • Conformity of the Technical Documentation and UK Declaration of conformity
  • Perform Post-Market Surveillance (PMS) and Vigilance Reporting

Education and Work Experience Requirements:

  • Higher education diploma in medicine, pharmacy, or another scientific discipline (medicine and pharmacy diploma holders will be given preference) and at least 2 years of experience in Regulatory Affairs or Quality Management System on medical devices.
  • Candidates without relevant higher education diploma can be considered if at 4 years of related experience in Regulatory Affairs or Quality Management System on medical devices. Preference will be given to candidates with relevant experience in the following fields:
    • • Medical device testing and/or inspection;
    • • Medical product design;
    • • Clinical evaluation;
    • • Quality management assessment in the medical industry, e.g. assessment to ISO 13485, GMP assessment.