Quality Assurance and Regulatory Affairs Specialist (Medical Device)

Higher education degree – preferably in a technical field (e.g. Biomedical Engineering) or related to Quality Management, Minimum 3 years of professional experience in the medical device industry (QMS and/or Regulatory Affairs), Experience working with medical device technical documentation, Practical knowledge of ISO 13485, including experience in independently conducting audits, Practical knowledge of MDR (EU) 2017/745 requirements, Experience or familiarity with global market registration processes, Fluency in Polish (C1/C2), English proficiency at a minimum B2 level, Ability and confidence in drafting documentation (in both Polish and English), Very good knowledge of MS Office, particularly Word and Excel, High level of accuracy, attention to detail, and commitment to assigned tasks, Very good work organization skills, Ability to work effectively in a team, Internal Auditor ISO 13485 certification will be considered an asset, Knowledge of ISO/IEC 27001 requirements, Familiarity with the Scrum framework and Scrum@Scale

sharing the costs of sports activities, private medical care, remote work opportunities, flexible working time, integration events, no dress code, coffee / tea, employee referral program