Our client is a thriving start-up in the digital health space, who have created a highly innovative app that provides personalized musculoskeletal digital training programs for rehab and recovery. They were among the first companies in Germany to achieve DiGA status and be successfully rolled out for use by patients and healthcare professionals. They are headquartered in Berlin but this position can be based 90% remotely.
To strengthen the RA/QM function in the team, they are searching for a Quality Specialist to provide support with new product development & software lifecycle & of course, the transition to MDR. It is an extremely exciting time to join as, on top of their success with DiGA and MDR, there is new product development in the pipeline and the growth potential is huge – they will replicate their success and build more digital health products for other conditions and you could be a part of this!
- Development and maintenance of the Quality Management System (according to ISO 13485).
- Development and maintenance of Information System Security (according to ISO 27001).
- Updating and maintenance of technical documentation (according to MDR).
- Participation including planning and implementation of internal and external audit processes.
- Management of CAPA processes.
- Support expansion into new markets.
- 2+ years of experience in Quality Management for medical devices, preferably in the field of SaMD (DiGA or stand-alone software).
- Strong knowledge of applicable medical device regulatory requirements and standards (ISO 13485, 27001 and DiGA-V etc.).
- Willingness to learn and apply new skills and keep up to date with new market requirements and regulations.
- Practical way of thinking and high level of initiative – ability to find solutions.
- Fluency in German and English – spoken and written.
Please contact Hollie Barry for more information on this opportunity, and others in RAQM.