Freelance Quality

2 giorni fa

milano, Italia VLF Consulting A tempo pieno

Who we are Velferd, 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. Required skills: Several years of experience in quality management systems and regulatory compliance for medical devices. In-depth knowledge of key industry standards, including: ISO 13485 (Medical devices — Quality management systems — Requirements for regulatory purposes) IEC 60601 (Medical electrical equipment) IEC 62304 (Medical device software — Software life cycle processes) ISO 27001 (Information security, cybersecurity and privacy protection — Information security management systems — Requirements) Regulatory knowledge of MDR 2017/745 and FDA regulations for the US market. What we offer: A fully remote collaboration with flexible activity management. Integration into a dynamic and innovative environment focused on quality and regulatory compliance. The opportunity to actively contribute to the development and improvement of company processes. Note: Only applications that meet the required qualifications will be considered.

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