Project and Study Lead System Verification (IVDR) 100% 100%
Inseriert am: 20.03.2019
We are looking from June 2019 on until the end of February 2020 (with option for prolongation), for our Contract Partner Roche Diagnostics International Ltd. in Rotkreuz, for a Project and Study Lead System Verification (IVDR) 100%.
Main tasks:
You are responsible for testing of system product specifications, e.g. analytical performance, overall system reliability etc. as required by IVDR
You are 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
You 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
The advertised position offers:
Working in an interdisciplinary environment with scientists, engineers and lab specialists from various disciplines
You are the 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
Must-have requirements:
Be experienced in testing, verification and specification of analytical systems comprising chemical assays
Know the regulatory requirements and guidelines for verification of in-vitro-diagnostic assays. Preferably, you contributed in the past to regulatory submissions in direct contact with authorities
Be experienced in planning, execution and evaluation of analytical studies
Have a background in chemistry, biology, lab medicine or other natural sciences (MSc, PhD or other further education)
Be a people leader and a good communicator at the interfaces and with stakeholders
Fluent in English with good German skills
Important : Hepatitis B vaccination required Are you interested? Eva Schwerzmann is looking forward to your complete application document, incl. a motivation letter regarding all the requirements.
