Hello, we are easee! A high-tech healthcare startup offering the world's first CE-certified online eye exam that you can do at home with just a computer and a smartphone. We offer tele-health solutions for hospitals and we make it much easier to get new glasses or contacts online with the right prescription values. We save our customers the time to visit a hospital or optician. Our mission is to make clear vision accessible to everyone. Try it yourself at easee.online.
Our easee values are important to us: courage, impact, curiosity, quality and honesty. And at least of the same significance are our team values: open mindedness & respect. What do all these words mean?
- Be open minded about everything, only that way you can learn something new.
- Respect is one of the most important values when it comes to teamwork. It’s pretty simple: Treat others the same way you want to be treated.
- If you have a good idea and are not 100% sure if you can do it, tend to just do it. It is better to ask for forgiveness than permission.
- We make decisions based on the principle of “disagree and commit”. Getting everyone to fully agree on a plan is hard and takes too much time. Instead, we make decisions quickly and follow through.
- We value efficiency and personal growth and have the resources available to make this happen.
About the job
Easee is a SaMD company that's EN ISO 13485:2016 certified. We expect you to lead our MDR transition, to maintain our QMS and work with R&D, Customer Support and Management to ensure compliant processes and products. We see Regulatory Compliance as a key differentiator and host a Meetup group for SaMD professionals. We offer you the opportunity to lead the way in regulatory compliance for low-risk agile software development and to show off!
What we expect
- Develop and execute company’s regulatory strategy working closely with senior management team
- Manage and supervise company quality management system
- Perform periodic internal and external audits on company procedures and processes
- Create, implement, and document processes together with internal cross-functional teams
- Lead our medical software certification process and oversee the continuous compliance for medical software in the EU (MDD, MDR)
- A university degree in a relevant area such as law, engineering or another scientific discipline
- Experience with Quality Management Systems compliant with ISO 13485
- At least two years’ experience within Regulatory Affairs and/or Quality Assurance for Medical Devices
- Knowledge of and experience with submissions under MDD/MDR/FDA is a preference
- Fluent English, second language is an asset
- Analytical, independent, result driven
This is what we offer!
- Be part of one of the most promising health-tech scale-up preparing to expand globally
- Work in a highly motivated and talented international team with flat hierarchies; that is taking easee to the next level.
- Freedom to execute your job in your way; we are results driven
- Regular team easee events such as celebrating successes with Friday afternoon demos and drinks, Ping Pong table and WII
- When you work in the office, a daily company lunch, free drinks and fresh fruits are provided by easee
- 25 holidays per year on a full-time basis & additional public holidays
- We invest in your personal development through training and education
- We are headquartered in beautiful Amsterdam in an inspiring start-up hub where we share offices with inspiring start-ups like Disney+, Relay42 and many more
- Learn in one year what normally takes five
- A full-time job where you are able to (partially) work remotely