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Medical Devices Quality Specialist

Join our team and develop innovations with us!

Your Tasks:

  • Participation in registration and certification procedures for the Company’s medical devices for the European and American markets
  • Maintenance and development of the quality management system
  • Participation in the creation and supervision of technical documentation of the product
  • Conducting internal audits and participation in external audits dictated by the formal requirements of the regulatory authorities of the medical devices market
  • Constant monitoring of regulations and requirements in the EU and the USA
  • Supporting the regulatory manager in everyday activities, including conducting internal training
  • Providing support for members of other teams in the regulatory area

What we expect from you:

  • At least 2 years of professional experience in regulatory issues or quality management systems in the field of medical devices
  • Higher education in the fields of medicine, biotechnology, medicinal chemistry, medical analytics, biomedical engineering
  • Knowledge of standards and formal rules for regulating the medical devices market in the EU and the USA (MDR, ISO 13485, FDA)
  • Knowledge of the English language, in speech and writing, to the extent that allows the preparation of documentation and formal applications to market regulatory authorities
  • Independent problem solving and communication, meticulousness and the ability to work on many parallel projects

Nice to have:

  • Formal qualifications of the ISO 13485 internal auditor
  • Experience in risk analysis and management
  • Experience in SaMD / MDSW projects (IEC 62304 standard) managed in accordance with agile methodology

The controller of your personal data is Hemolens Diagnostics Sp. z o.o., with its registered office in Wrocław, ul. Legnicka 48G, 54-202 Wrocław, Poland. Your personal data will be processed for the purposes of current and/or future recruitment processes. You can find more information about the processing of your data, including the scope of your rights, in our information clause on personal data processing in recruitment processes.

Apply now