Freelance Quality & Regulatory Specialist – Medical Devices (Full Remote)
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.Apply Now
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