Beschreibung
Project and Study Lead System Verification (IVDR):- IVD/laboratory /GermanProject / Role: For our customer, a renowned pharmaceutical company in Switzerland, we are looking for a Project and Study Lead System Verification (IVDR) Specialist. The role is a contract position initially for 8 months (with strong possibility of extension) in Luzern Switzerland.
Main tasks:
-He/she will be responsible for testing of system product specifications, e.g. analytical performance, overall system reliability etc. as required by IVDR.
-He/She will be responsible for budgeting, tracking and reporting of all activities, and you are the study lead, i.e. ensure detailed planning and execution of the studies as well as evaluation and documentation of results .
-Responsible to lead a team consisting of trained lab personnel and scientists. Your main interfaces include the program development lead, regulatory affairs, clinical operations, design quality assurance and project controlling.
-Should be willing to work or have earlier worked in an interdisciplinary environment with scientists, engineers and lab specialists from various disciplines.
-He/she will be working as a technical lead of highly skilled employees. In this capacity, you will ensure the availability of resources, materials, samples, lab infrastructure and software tools for result evaluation
-Working in a regulated market. You will ensure that tests are executed according to international guidelines and internal processes, and you will be responsible for demonstrating substantial equivalence to predicate devices. You are also part of the interdisciplinary team for registration activities with notified bodies
Requirements:
-Should have good experience in testing, verification and specification of analytical systems comprising chemical assays.
-Know the regulatory requirements and guidelines for verification of in-vitro-diagnostic assays.
-Should have good experience in planning, execution and evaluation of analytical studies.
-Willing to work as a people leader and a good communicator at the interfaces and with stakeholders.
Education: Bachelors/Master's degree with background in chemistry, biology, lab medicine or other natural sciences (MSc, PhD or other further education)
Languages:
German - Fluent
English - Fluent
Reference No.: 918150NC
Role: Project and Study Lead System Verification (IVDR ) Specialist
Industry: Medical
Location: Luzern und Region
Workload: 100%
Start : 01.06.2019
Duration: 8 months+
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
About us: ITech Consult is a certified ISO 9001:2008 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.