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.