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.