Loop Medical is a startup company on a mission to simplify blood collection. More than 10’000 blood samples per minute are collected worldwide, using the venipuncture technique that has hardly evolved in the past 50 years. We are developing a painless and easy-to-use solution able to collect a large amount of capillary blood. Loop’s unique technology is compatible with the infrastructure of central laboratories, guaranteeing high clinical standard blood analysis.
Loop Medical, established in 2016, is supported by the Bill & Melinda Gates Foundation and by the Horizon 2020 programme of the European Union. Loop partners with Cerba Healthcare, a European leader in clinical pathology.
We are looking for a QA/RA Manager, to lead the clinical activities of the company. You will plan and run clinical validations in close collaboration with our clinical partners. You will establish a Quality Management System, in coordination with our manufacturing partners. Finally, you will be in charge of regulatory affairs to get approval for Loop Medical’s product. You will work in a dynamic startup environment, in close collaboration with the CTO and COO, to grow the company. We are looking for an enthusiastic entrepreneur, with a problem-solving approach and critical thinking.
Oversee the clinical activities, in line with the strategic imperatives.
Put in place and maintain a Quality Management System
Design, budget and plan the clinical validations.
Run clinical validations of the product in collaboration with our partners.
Lead the Regulatory Affairs and coordinate with external consultants.
Acquire and maintain a deep knowledge of the market needs.
As the company grows, recruit new talents for the clinical team.
M.Sc. or PhD in Quality engineering or equivalent.
5y+ experience in the development of Medical Devices.
Experience with international norms ISO 13485 and ISO 14971
Prior experience as Quality and/or Regulatory Manager
Prior experience with interacting with regulatory bodies (CE & FDA)
Ability to actively communicate, inspire and motivate.
Ability to think and act strategically and proactively.
Strong written and oral communication skills.
Starting date: as soon as possible.
Send your application to: email@example.com