May 19, 2021

Global Head of Quality Management

  • Kaia Health
  • MUNICH, GERMANY
Full time Quality

Job Description

Kaia is a mission focused medical technology company: Kaia Health was founded in 2016 with the mission of bringing affordable and accessible relief to millions of chronic disease patients. Using innovative technology, we develop digital mind-body therapies that provide better affordable care. Our products are a clinically-proven therapy for relieving back pain, hip and knee pain as well as COPD. Our mobile app gives users access to multimodal pain therapy, the gold standard of therapies in pain medicine. Kaia’s AI powered algorithm provides users with real-time feedback on their exercise execution using their phone. Today we are one of the market leaders in digital therapeutics globally, with 500,000+ users. We have raised a total of $125 million from investors like Optum Ventures, ID Invest, Balderton Capital and other top tier healthtech investors. We are building an exceptional team based in Munich and New York to succeed in our mission to bring affordable and accessible care to millions. Today we have more than 500.000 users across multiple apps and deployments. We are in the market as with two stand-alone software solutions regulated as medical devices in the EU and have a certified QM system according to ISO 13485 since 2016. The role: You take ownership of our QM system You constantly challenge, rewrite and teach our current SOPs based on how people actually work to make them as easy-to-use as possible You improve the QM system also conceptually, by thinking about the tooling we have in place (Confluence) and ways to improve it You lead and guide the QM team, currently consisting of 2, delegating tasks and coaching them to become the best version of themselves You are able to abstract complex relationships and dependencies and communicate them in a simple way e.g. in town hall meetings You like to teach others how to use processes and enable them to do the work You take ownership of the international regulatory strategy You stay on top of process changes in the company and align the appropriate strategic actions with management. You are able to research the intricacies and regulatory hurdles of entering new markets You find pragmatic and risk-adjusted solutions. Instead of a “no-sayer”, you are someone who enables the organization to grow further by proposing creative and risk-adjusted solutions Your profile: 3+ years experience in regulatory affairs for medical devices, preferably in stand-alone software as a device and knowledge of all applicable standards in the EU. Knowledge of FDA is a bonus. Experience with Quality Management Systems compliant with ISO 13485, ideally also compliant with 820 CRF part 21 Ability to own regulatory processes at the interface of development, clinical and business teamsKnowledge of agile software development processes and terminology Systematic problem-solving approach, coupled with strong English writing skills, strong sense of ownership and drive Good abstraction and communication skills to present regulatory topics to the rest of the company Ideally you also have: Experience in small and scaling startups A university degree in a relevant area Worked at the intersection of software development and regulatory before A knack for designing simple processes that fulfill all regulatory needs and enjoying the elegancy when they’re being used in production You'll fit in with our company culture if you: Are user centric and view technology as a tool to improve a user’s life Have a bias for action; the world is complex and unpredictable place so starting, releasing, and getting feedback iteratively is the only possible path to success Strive to be articulate and humble, make the complex simple, present ideas openly, accepting that being wrong is part of the process Are not afraid of tackling problems that others deem impossible Thrive in an entrepreneurial team, adapt easily to change, and enjoy a fast-paced environment Some of the benefits we offer: Directly shape the future of digital health with a competitive salary A workplace in the city center of Munich with good connections or remote working possible Flat hierarchies, flexible vacation and working times Work with a pragmatic, high performing team that cares about helping each other to get to the best results for patients Help over 70000 patients that actively use the app each month to improve their pain Personal development budget of 1200 Euro per year **The selection process for this role will begin in mid-January 2021** Some other things you will enjoy, specifically thinking about ‘the new normal’ post-COVID19 We have a sustainable, long-term impact: Most Kaianeers chose to work at Kaia and not at other companies simply because they want to have a lasting, positive impact on the world and not just talk about it. Providing remote access to the gold standard in management of chronic conditions already helps hundreds of thousands of users to reduce their suffering and win back quality time with their loved ones. Flexible working hours: You can manage your day so that it works for you and your family. We are interested in the outcomes of your work, not the face time you spent with work. Some more benefits listed on our website: https://www.kaiahealth.com/about-kaia/careers/ We value diversity and believe forming teams in which everyone can be their authentic self is key to our success.

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