easee
Compliance Manager
Amsterdam
Full time
About the job
Easee is a Software as a Medical Device (SaMD) company that's EN ISO 13485:2016 certified and is active in the EU and US. We expect you to lead our MDR certification, 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.
Our vision for SaMD is to have a great development cycle that allows us to respond to customer feedback rapidly, while still being fully compliant. This is how most non-regulated software is ensuring high customer satisfaction, and we believe that low-risk medical device software can operate in the same way, but we need your help to achieve this.
You'll be our Quality Management Representative and regularly attend senior management team discussions. You will be reporting to the COO and work closely together with our US Regulatory Affairs lead. We offer you the opportunity to lead the way in regulatory compliance for low-risk agile software development and to show off! We plan on expanding internationally and going through complex regulatory approval processes so there's a huge learning opportunity.
Our vision for SaMD is to have a great development cycle that allows us to respond to customer feedback rapidly, while still being fully compliant. This is how most non-regulated software is ensuring high customer satisfaction, and we believe that low-risk medical device software can operate in the same way, but we need your help to achieve this.
You'll be our Quality Management Representative and regularly attend senior management team discussions. You will be reporting to the COO and work closely together with our US Regulatory Affairs lead. We offer you the opportunity to lead the way in regulatory compliance for low-risk agile software development and to show off! We plan on expanding internationally and going through complex regulatory approval processes so there's a huge learning opportunity.
What we expect
- Make the QMS alive in a frictionless way in our organisation of 25 people, by being the advocate for quality and compliance
- 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 (with TÜV Rheinland) on company procedures and processes
- Create, implement, and document processes together with internal cross-functional teams
- Lead our medical software certification processes and oversee the continuous compliance for medical software in the EU (MDR)
About you
- A university degree in a relevant area such as law, engineering or another scientific discipline
- Experience with Quality Management Systems compliant with ISO 13485 and ISO 14971 and preferably IEC 62304 and IEC 62366
- You have the ability to make processes work for people
- 3 to 7 years of experience within Compliance, Regulatory Affairs and/or Quality Assurance for Medical Devices
- Knowledge of and experience with submissions under MDD/MDR/FDA is a preference
- Fluent in 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-ups preparing to expand globally
- 8% holiday allowance
- 25 holidays per year on a full-time basis & additional public holidays
- A competitive salary and an outlook towards participating in our employee Long Term Incentive plan.
- 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 #teameasee events such as celebrating successes with Friday afternoon demos and drinks, Ping Pong table and WII
- Daily company lunch, free drinks and fresh fruits are provided by easee
- 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. We plan to expand globally and adopt a QMS that is working really well for continuous software delivery.
- A full-time job where you are able to (partially) work remotely
How to apply
After your application, the hiring team will contact you for a first screening call with one of the team member that is responsible for this vacancy. This is a first introduction to get acquainted and to have the opportunity to ask your questions. If the outcome is positive, there will be a follow-up meeting with two team members from the hiring team.
easee
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 telehealth solutions for hospitals and also make it easier to order new glasses or contacts online with the correct prescription values, without the need for an appointment at the hospital or optician. Our mission is to make clear vision accessible to everyone. You can try it yourself, right now, at easee.online.