Medical Expert for Medical Device Risk
vor 7 Monaten
**Kaia is a mission-focused health technology company.**
Our story began in 2016, when our founders Konstantin Mehl and Manuel Thurner, set out on a mission to bring affordable and accessible relief to millions of people with chronic conditions. No strangers to chronic pain themselves, they decided to innovate ways to remove the obstacles many people experience in getting the leading-edge care they need in order to live their best lives.
How do Kaia apps work? Kaia uses a dynamic AI-powered algorithm. Our programs are based on multimodal rehabilitation, a holistic approach to managing chronic conditions. Our users have easy access via smartphone and tablet to our programs for back/hip/knee pain and COPD using this evidence-based approach.
Five years into our story, we are a leader in digital therapeutics, with 500,000+ users worldwide. Having raised $125 million from investors such as Optum Ventures, idInvest, and Balderton Capital. We are poised to create a global footprint in digital self-care; Kaia is patient empowerment made easy.
The regulatory landscape is quickly adapting to the digital ecosystem. Therefore, our mission and strategy bring new opportunities for exceptional talent to join our journey. With over 100 "Kaianeers" spread across the globe, we need now, more than ever, specialized talent to help take our mission further.
**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.**
**Some of the benefits of being a Kaianeer**:
- 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.
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Medical Expert for Medical Device Risk
vor 7 Monaten
Berlin, Deutschland Kaia Health Software GmbH Vollzeitat Kaia Health Software GmbH Berlin, Berlin, Germany **Kaia is a mission-focused health technology company.** - Our story began in 2016, when our founders Konstantin Mehl and Manuel Thurner, set out on a mission to bring affordable and accessible relief to millions of people with chronic conditions. No strangers to chronic pain themselves, they decided to...
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