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 specialised and innovative devices and test kits. Our
company is characterised by steady and sustainable
growth in an international future-oriented business field.
To strengthen our team at the Mainz site, we are
looking for a
Clinical
Affairs Associate
(m/w/d)
Main Tasks:
·
Support
preparation, maintenance, and management of design documentation of legacy IVD products.
·
Support
the creation of IVDR compliant clinical evidence documentation including study
plans and reports for regulatory submissions (PEP/PER, CPR, SVR, SOTA).
·
Contribute to coordination
and implementation of clinical studies that support regulatory submissions, including
pre-market approvals (PMA), 510(k) notices, and CE marking.
·
Contribute
to post-market performance follow-up studies and surveys to ensure ongoing
compliance throughout the product lifecycle.
·
Perform
systematic literature research to support scientific validity and state of the
art and post market surveillance.
·
Ensure
compliance with all regulatory standards across different regions, including
FDA, EMA, and other international regulatory agencies.
·
Ensure
compliance with legal and regulatory requirements across different
jurisdictions, including adherence to Good Clinical Practice (GCP), ISO
standards, and relevant in-vitro diagnostic device regulations (IVDD/IVDR).
Skills:
·
Master’s
degree or higher in a relevant life science discipline, e.g. biology,
biochemistry, chemistry; a PhD is preferred.
·
Minimum
of 3 years of working experience in R&D, preferably in the IVD industry or
medical device industry, a strong background in autoimmunity and infectious
diseases would be beneficial.
·
Careful, accurate and
responsible way of working, good documentation practice
·
Experience
in technical, scientific or medical writing and document management.
·
Strong
analytical and problem-solving abilities.
·
Understanding
of standard landscape (ISO, CLSI, 21CFR)
·
Confident
in the use of MS-Office and statistical software, knowledge of document
management systems would be a plus.
·
Proficient
in German and English
Benefits :
·
Permanent 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
Would you like to work in an exciting research field
with a great team? 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.