ORGENTEC Diagnostika
GmbH is the global market leader in the development and production of test
systems for the diagnosis of infectious and autoimmune diseases. As part of the
Sebia Group, headquartered in Lisses/France, ORGENTEC supplies medical
laboratories in over 100 countries with highly specialized and innovative
devices and test kits. Our company is characterized by steady and sustainable
growth in an internationally oriented, future-oriented business field.
To
strengthen our team at the Mainz site, we are looking for a
Main
Tasks:
Support
the R&D team in analytical and clinical performance evaluation of
products and stability studies and their data analysis and documentation by:
·
Prepration of analytical evaluation protocols
·
Data evaluation (internal/external performance data)
by using statistical tools
·
Preparation of performance study reports
·
Support the Post-marked Performance Follow-up process
·
Support the creation of templates for Clinical
Evidence requirements
·
Drive projects across various global Sebia sites and
work with external collaboration partner
Skills:
·
Master`s degree in biology, biotechnology,
biochemistry, or similar; advanced graduate degree (PhD) is a plus
·
Experience in technical and scientific writing for
regulatory audiences such as Notifed Bodies, FDA or other authorities is a plus
·
Strong analytical and strong quality management
thinking
·
Interest and understanding of regulatory landscape
(IVDR, ISO, CLSI, 21CFR)
·
Understanding of complex performance data with
excellent data presentation skills
·
Experience in statistical tools for data analysis,
especially Excel, additional tools are a plus
·
Enjoy working in a team
·
Careful, accurate and responsible way of working
·
Good documentation practice
·
Confident in the use of MS-Office
·
Fluent in English, German is a plus
Benefits:
·
Fixed-term employment contract
·
A crisis-proof job with an attractive income
·
Annual salary review
·
Flexible working hours
·
Individualised employee development and training
·
Attractive package of health and social benefits (e.g.
subsidised computer glasses, flu vaccination, employer contribution of 30% to
private pension scheme)
·
Employer subsidy for the canteen, free drinks
·
Crèche and kindergarten allowance (max. €200)
·
Employee discounts with well-known brands
·
Anniversary bonus
·
Car park directly at the company
Are
you interested?
We look forward to receiving your application
(cover letter, CV, references) by e-mail to jobs@orgentec.com . Please state
your salary expectations and a possible starting date.
ORGENTEC
Diagnostika GmbH
Contact: Therese
Koal
Carl-Zeiss-Straße 49-51
55129 Mainz