Quality&Regulatory Affairs Technician

3 semanas atrás

Porto, Porto, Portugal FAPOMED - DISPOSITIVOS MÉDICOS, SA Tempo inteiro

FAPOMED, manufacturer of medical devices worldwide, is looking for a Quality and Regulatory Affairs Technician for its headquarters in Felgueiras/Portugal.



THE RIGHT PROFILE FOR SUCCESS

  • Degree in Biomedical Engineering, Biology, Biotechnology or related areas;
  • Excellent knowledge of Medical Device Regulation (MDR) with experience in the manufacture of Medical Devices - risk class I sterile and IIa (mandatory);
  • Experience and autonomy in drawing up technical documentation for medical devices in accordance with the MDR for systems and assemblies;
  • Experience and autonomy in the area of Quality systems management (ISO13485) and the regulatory area of medical device manufacturing;
  • Advanced written and spoken English (mandatory);
  • Organized, detail-oriented, proactive and persevering profile.

RESPONSIBILITIES

  • Manage the implementation of the New Medical Devices Regulation (EU) 2017/745 for the product portfolio including all activities related to regulatory aspects (Clinical Evaluation, Biological Evaluation, Risk Management, PMS, PMCF and other related);
  • Provide technical support in the management of Quality Management System processes within the organization's processes in line with ISO13485 and its related activities.

Visit us:

  • Please send your CV to the email: @

We want to be contacted by candidates with experience in MDR from the point of view of Medical Device Manufacturing.

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