Project duration: 2 - 3 weeks
Chargeable rate: $350 - $500 (daily)
The primary responsibility is to validate the development and execution of comprehensive risk management for Kaia's medical devices (Kaia Back Pain and Kaia COPD). The clinician will work closely with Compliance and Engineering to identify, assess, and mitigate risks associated with our devices and enabling the team to update and maintain a comprehensive Risk Assessment Table as per the ISO 14971 Risk Management Standard.
Also, the role will require reviewing product changes which, if deemed as a significant change, could lead to re-evaluation by TÜV SÜD and BfArM.
Additionally, providing medical safety stewardship of our products, specifically supporting case reviews or any adverse events reported in the field will be required. Support in the technical documentation such as the Periodic Safety Update Report (PSUR, as per the EU MDR), Product Trend Analysis benchmarking based on the other products available in the market.
- You can directly influence the future of digital health in a team of industry experts and digital shapers.
- You will work alongside serial entrepreneurs (previously founded and scaled another startup, Foodora).
- You’ll enjoy accessible leaders, a hybrid (home/office) or remote work environment, and flexible vacation and working times.
- We support your professional development and have a budget and PTO set aside for you just for that!
- Happy hours, team events, and knowledge-sharing sessions.
- Join us if you’re looking for an entrepreneurial adventure and an exciting place to grow personally and professionally.