PbWho we are /b /ppVelferd, and in particular its brand VLF Consulting, is an innovative multi-services hub supporting companies in the development of new ideas and solutions in life science world, with a strong focus on Regulatory Affairs and Quality Assurance aspects of medical devices. /ppbr/ppbRequired skills: /b /pulliSeveral years of experience in quality management systems and regulatory compliance for medical devices. /liliIn-depth knowledge of key industry standards, including: /lilibISO 13485 /b (Medical devices — Quality management systems — Requirements for regulatory purposes) /lilibIEC 60601 /b (Medical electrical equipment) /lilibIEC 62304 /b (Medical device software — Software life cycle processes) /lilibISO 27001 /b (Information security, cybersecurity and privacy protection — Information security management systems — Requirements) /liliRegulatory knowledge of bMDR 2017/745 /b and bFDA regulations /b for the US market. /li /ulpbr/ppbWhat we offer: /b /pulliA fully remote collaboration with flexible activity management. /liliIntegration into a dynamic and innovative environment focused on quality and regulatory compliance. /liliThe opportunity to actively contribute to the development and improvement of company processes. /li /ulpbr/ppbNote: Only applications that meet the required qualifications will be considered. /b /p