Cooperating with Team Leaders in the development of the product backlog
Supervising the work of project teams and assessing the actual progress of products
Ongoing communication with TL, Programme Manager, Management Board to inform them about problems, change proposals, risks in the project
Coordinating work on preparation of the system for registration and market authorisation
Overseeing the application of applicable standards and regulations in collaboration with Team Leaders during design work.
OUR REQUIREMENTS
Knowledge of Directive 98/79/EC on in vitro diagnostic medical devices, as well as Regulation (EU) 2017/746 (IVDR) will be an advantage.
Good knowledge of material, personnel and financial scheduling software.
Knowledge of English at least at the C1 level.
Higher technical education, Master’s degree in physics, biochemistry, chemistry or biomedical engineering preferred.
Experience in work with ISO standards and ability to apply them in practice.
A minimum of one year’s experience in the diagnostics or pharmaceutical sector is welcome.
Experience in work with Quality Management System in accordance with ISO 13485:2016
Experience in certification of medical devices, submission of applications, keeping contact with the Office for Registration of Medicinal Products, Medical
Devices and Biocidal Products will be an advantage.
WHAT WE OFFER
Employment on an employment contract or B2B basis.
Attractive and flexible terms of employment.
Work on a unique implementation project on a global scale.
Work on a revolutionary system for medical diagnostics.
Outstanding opportunities for professional development working on projects involving cutting-edge technologies.
Employment on an employment contract or B2B basis.
Attractive and flexible terms of employment.
Work on a unique implementation project on a global scale.
Work on a revolutionary system for medical diagnostics.
Outstanding opportunities for professional development working on projects involving cutting-edge technologies.
ABOUT SCOPE FLUIDICS
Scope Fluidics is an incubator of technology start-ups creating medical diagnostic systems in response to the biggest global threats in healthcare. Currently, Scope Fluidics Group is developing two special purpose companies: Curiosity Diagnostics developing the world's fastest system for infections detection – PCR|ONE, while Bacteromic is creating the most informative system for determining drug susceptibility of bacterial pathogens.
Scope Fluidics is a group of more than 50 specialists of different disciplines and temperaments, focused on finding innovative solutions. We create groundbreaking medical diagnostic systems in response to global healthcare challenges. From an idea to the finished product
