We are the digital health company behind Sensor Dot, a powerful wearable platform for 24/7 acquisition of physiologic and behavioral data. We have developed remote monitoring applications for COVID-19, epilepsy and cardiovascular diseases, and have a pipeline of additional clinical indications.
Byteflies is structured in autonomous cross-functional teams that all have skills to complete their own part of the Byteflies mission. All of these teams have great autonomy in reaching their goals. We are looking for an entrepreneurial colleague for the Regulating the Dots team with lots of energy and passion to spread the telemonitor gospel and change the lives of patients and healthcare professionals.
Regulatory Affairs at Byteflies: what does that mean?
Byteflies has developed a modular regulatory strategy that marries agile design and development principles with EU and US medical device regulatory requirements. Our aim is to get Care@Home applications approved quickly and safely, with an agile design philosophy in mind.
This requires a very deep understanding of our product and the regulatory environment. The Regulatory Affairs Manager plays a pivotal role: you ensure that the organization complies or operates in conformity with its outside regulatory and legal requirements, as well as internal policies and bylaws. You train & coach staff in regulatory policies or procedures. DHF review and guidance is part of your work. You’ll also be the liaison to regulatory authorities, lead internal audits, and monitor changing standards. You will work closely with our Quality Manager & Chief Medical Officer to develop regulatory strategies and implementation plans for the preparation and submission of new products as well as developing & maintaining procedures & policies. You’ll be the Management Representative under the ISO 13485 and responsible for regulatory compliance under the MDR.
What we will be on the lookout for
- Degree in Biomedical Sciences, Engineering or equivalent.
- Background in Quality Management Systems and/or ISO certifications in the EU; knowledge about the US regulatory environment is a plus
- Good communicator, ability to teach, train & coach teams on all things regulatory
- Fluent spoken and written English; ability to read & comprehend Dutch & French
- You know how to train & coach people and teams in this domain. You know how to raise awareness for quality, regulatory & customer requirements in a positive way
- You’re organized, and know how to structure your work both for the short & long term
- You are a team player and are willing to take on a variety of tasks
- You are at your best in a fast-paced and multidisciplinary environment, you’re willing to go the extra mile to learn from and train your colleagues
- Knowledge and possibly experience of agile & lean principles and how you can marry the world of ISO standards, strict regulations and agile product development is a huge plus
- A possibility to take part in our journey to enable out-of-hospital monitoring and the chance to have a direct impact on people’s health care
- Growing with Byteflies will unlock rapid professional growth and lots of new challenges
- A bunch of awesome colleagues who will challenge you to keep learning
- A working environment based on real autonomy & responsibility
- A hybrid work environment: our main office is in Antwerp: we come to the office when we want to, and when we need to. Nobody will regulate your time in office vs remote work
- A competitive salary and benefits package is of course part of the deal