Today, more people die from suicide than from war, crime and terrorism combined.
Our mission is to develop new ways to combat mental health issues with science and technology.
Our first product, Flow, is a medication-free treatment for depression, the leading cause of disability in the world. It combines a brain stimulation wearable and an app-based therapy program to create a new effective, safe, and affordable way to treat depression, at home.
Our team consists of neuroscientists, psychologists, animators, senior game developers and Harvard students from top management firms.
We are now looking for a Regulatory affairs manager to complement us and be part of the Flow team.
This position is for you, if you:
- want to bring a new treatment to the world to a disease that affects 300M people worldwide.
- want to work in the intersection of medical technology, digital health, hardware, psychology and artificial intelligence.
- have a strong passion and integrity for what you do and want to challenge the way we treat mental health problems today.
- be one of the first employees in a startup with truly global potential and ambitions, and be a part of shaping the culture and future of the company.
The purpose of this position is to ensure that Flow is compliant with relevant regulations as we expand globally (right now Flow is CE marked in Europe).
Amongst other things you will:
- Manage the core regulatory dossier, life cycle management and compilation of submissions for our product Flow in relevant markets.
- Maintain and improve our existing quality management system and processes.
- Work strategically together with our business team, and proactively identify new markets to file for submission in.
- Creation and review of regulatory documentation relevant for submission.
- Co-ordinating consultants in applicable markets.
- Product Information – creation, revision and translations to local languages and/or coordination of these activities.
- Ensure updates of applicable national databases.
If you have a good profile and are passionate about how to tackle mental health issues with tech we can offer you:
- Extremely committed co-workers
- A chance to work with a truly unique product with the potential to change millions of lives for the better
- A competitive salary that will grow with the success of the company
- A generous options package
- Access to an amazing network within science (the first and foremost researchers in brain stimulation are on our medical advisory board), finance (Silicon Valley based Khosla Ventures is our lead investor), the hardware startup scene (we are both HAX alumni (http://hax.co/) and members of the Hardware club (https://hardwareclub.co/)), PR (we work together with a passionate PR firm with experience from healthcare products, based in London)
Skills and experiences we are looking for
We would love to hear from you if you have 5+ years of experience of working with medical device quality and regulatory affairs with submissions of medical technology products in Europe and elsewhere. It is highly advantageous if you also have experience with US FDA filings. You are fluent in English.
Experience working according to all or any of these standards/regulations is a merit: MDD & MDR, FDA QSR, MDSAP, ISO 13485:2016, IEC 62304, ISO 14971, IEC 60601.
We are ambitious, focused on doing rather than talking, are analytical and passionate about the problem we are trying to solve. If you think these are traits you also possess we would be honored to hear from you.
Last but not least...
Desired personal qualities:
- Intellectual breadth
- Ability to admit when wrong
- Ability to work in a diverse team
- Sense of humor
- Emotional openness
The position is based in Malmö, Sweden. Several members in the team work remotely from time to time.
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