Project and Study Lead System Verification (IVDR) (m/f/d)

REFERENCE NUMBER:

405059/11

MY DUTIES:

-Testing of system product specifications, e.g. analytical performance, overall system reliability etc. as required by IVDR
-Budgeting, tracking and reporting of all activities
-As study lead, ensure detailed planning and execution of the studies as well as evaluation and documentation of results
-Lead a team consisting of trained lab personnel and scientists and interface with program development lead, regulatory affairs, clinical operations, design quality assurance and project controlling
-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, ensure tests are executed according to international guidelines and internal processes

MY QUALIFICATIONS:

-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
-Preferably, you contributed to regulatory submissions in the past in direct contact with authorities
-You are experienced in planning, execution and evaluation of analytical studies
-You have a background in chemistry, biology, lab medicine or other natural sciences (MSc, PhD or other further education)
-You are a people leader and a good communicator at the interfaces and with stakeholders
-Proficiency in English; good German skills

MY BENEFITS:

-Reputable company

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Yves Fabien Deschamps

Reference number
405059/11

Contact
E-Mail: [email protected]