Small, senior and embedded.
qointa works on digital health technologies in regulated research. Our people have run clinical trials, built eClinical platforms, taken a device through EU MDR, owned regulated systems inside sponsors and held accountable quality and regulatory roles.
The work
Assignments combine regulatory reasoning with delivery: classify what a device does in a protocol, record the decision, identify what would change it and help the team put the necessary controls into operation. We do not sell a delivery pyramid; clients work with the people responsible for the judgement.
How we work
The firm is direct, evidence-led and distributed across EU and US time zones. We publish our method, keep decisions versioned and say when a request sits outside our specialist scope.
Who we hire
Senior people with one of four backgrounds: quality and regulatory affairs with device software experience; computer system validation and data integrity, including the move from CSV to CSA; clinical operations with hands-on DHT or decentralised-trial deployment; or medical device software development under IEC 62304. Most of our people have held an accountable role — PRRC, QP, legal representative, trial lead — and all of them have been audited against something they wrote.
What you get
Your name on the work. You own the assessment, sign the register entry and give the readout; there is no layer between you and the client. Engagements are fixed-scope with a stated delivery date, so the work has edges. We are a Belgian company with a US presence, distributed across EU and US time zones.
Introduce yourself
If none of the roles we are always looking for fits exactly and your experience is in clinical operations, medical devices, regulated software, quality or data integrity, send a short note describing the decisions you have owned to info@qointa.com.
