Person Responsible for Regulatory Compliance

Job Reference Code: WIG000018
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Person Responsible for Regulatory Compliance

Medical Technology POSITION FILLED
Discretionary Bonus
Key Responsibilities:
  • Monitoring and reporting on the production process from beginning to end maintaining quality in line with regulations
  • To ensure that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
  • Responsible for the technical documentation and the EU declaration of conformity that are drawn up and kept up to date
  • To compile and report the post-market surveillance obligations in accordance with the requirement of the EU MDR (2017/745).
  • Reporting obligations are fulfilled such as serious incidents, field safety corrective actions and trend reporting amongst others.
  • Ensures that clinical investigations are carried out as requested by the EU MDR (2017/745).
  • Final product release
Qualifications & Skills:
  • A diploma, certificate or other evidence of formal qualification, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and
  • At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; or
  • Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Other:
  • Most likely will come from a Quality Control or Assurance position with a Pharma or manufacturing company
  • 1-3 years experience
  • Willing to learn
Salary Comment:
  • None