Regulatory Affairs Manager for a Health App - remote option
Full time
Who we are
NeuroNation is the personalised Brain Training app that empowers more than 20 million people all over the world in staying brain healthy and happy in their lives.
We collaborate closely with scientists and universities to achieve the best results possible. Our engaging apps have received awards from major health insurance companies, such as the AOK, funded by the German Federal Ministry of Health. Also, we've been awarded by Apple and Google as one of the best apps available.
Next, we are looking forward to entering the medical market with a variant of our NeuroNation app developed as a medical device.
So, if you want to help us shape a better tomorrow, join us on our journey!
Your Roles and Responsibilities
In this role, you will be one of the main drivers to continuously develop our digital medical device (“NeuroNation MED”) and the underlying organisation, so that we achieve and keep reimbursement status by health insurances. In Germany, this is tied to getting an approval as a DiGA (“Digitale Gesundheitsanwendung”), and keeping up with regulatory changes. Other countries in Europe are expected to follow Germany’s lead in future, starting with France.
Since the role touches many different fields, you don’t have to bring all know-how already with you - we are welcoming passionate learners who want to develop themselves in this role, given you have solid knowledge of MDR or MDD.
It’s a hands-on role. Details depend on how much knowledge you already have. Here's the comprehensive list:
- Define the roadmap for NeuroNation to be successful as a Medical Device and be prescribed by specialists as a treatment for mild cognitive impairment
- Ensure compliance to relevant regulations, such as MDR / ISO 13485 / IEC 62304 / ISO 27001 / GDPR
- Actively work on definition and training of processes and documents for use in the relevant systems, such as the Quality Management System, the technical file, the Information Management System
- Use the product, review data, and derive ideas for improving real life outcomes for patients
- Actively collaborate with colleagues from IT / QA / Product / Science / Management and our regulatory consultants get approved by the BfArM on the German market, and to sustain this status
- Continuously conduct Risk-Benefit analysis and ensure that all workstreams incorporate a risk management process, interpret these risks in terms of business impact, and ensure appropriate risk responses are in place.
- Establish project and process metrics to measure the success and progress, identify key areas of opportunity, and drive process improvements.
- Work closely with the Technology & Product Management departments
- Ensure processes to comply with Post-Market Surveillance requirements
- Identify needs and trends to ensure we offer the highest value to patients and health professionals
- Share learnings and support team members to understand regulations and requirements
- Develop a Growth mindset - you constantly look for learning opportunities for yourself and the team
Requirements
- Must-Have: Located in a timezone +-2h from Berlin (CET) inside the EU
- Must-Have: Solid experience writing clean and compact technical documentation under MDR and ISO 13485
- Must-Have: Bachelor's degree or higher
- Must-Have: Excellent written and oral communication skills in English
- Must-Have: Deep interest in digital health (e-Health) and the capabilities of the brain
- Must-Have: Interest to develop your career towards a PRRC role, if not qualified yet
- Bonus: Experience with software development
- Bonus: Experience with ISO 27001 (or other standards for maintaining an ISMS), GDPR
- Bonus: Knowledge of DiGAV in Germany
- Bonus: German-speaking, as it would help dealing with local authorities’ requirements
Our offer
- Create something that is of real value to people, helping them to improve their lives
- Create something exciting, instead of spending your life with boring corporate, agency or advertising jobs
- Revolutionise the health and education systems
- Work partially or fully remote
- Flexible working hours
- Full-time preferred, part-time also considered depending on level of autonomy
- If you prefer regularly working in the office, a desk can also be provided at our Berlin office
How to apply
Please apply here:
https://tinyurl.com/nn-regulatory
NeuroNation
NeuroNation is a digital health company with the mission to help millions of people to regain, maintain, and improve cognitive and mental health.
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