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Who are we?
German company specialised in international regulatory affairs for medical devices and in vitro diagnostics is looking for regulatory affairs expert. The spirit of partnership is important to us – not only in our relationships with our clients and partners but also in the relationships among the individuals who work for CEplus. Our business culture is based on open communication and on a structure that accommodates each individual’s knowledge and skills. As an ambitious and progressive independent Regula- tory Affairs service provider, we offer the opportunity for an IVD expert to join our team based in Southern Germany near Basel .
What we offer:
As a regulatory affairs expert (m/f/d) on in-vitro diagnostic (IVD) medical devices you will focus on the regulatory support of IVD and companion diagnostic (CDx) products throughout the entire product lifecycle. You will have the opportunity to work on a variety of different projects within our CEplus team and you will be involved in various tasks, such as:
· Ensure fulfillment of EU requirements (IVDD 98/79/EC, IVDR 2017/746)
· Compilation of Technical Documentations
· Interactive collaboration with in-house experts covering all subjects related to CE-marking of IVDs (preclinical experts, clinicians, QM experts, etc.)
· Implementation of quality management systems, e.g. according to EN ISO 13458:2016 or MDSAP
· Close interaction with international clients as well as Notified Bodies and Competent Authorities
· Development of creative solutions in order to fulfill client needs combined with regulatoryrequirements
· Abackground in natural sciences, med tech, engineering or equivalent
· Experience with key topics of IVD related regulatory affairs/QMS:
o CE-marking of IVD products (preferably both reagents and instruments)
o Quality management systems (EN ISO 13485)
· Preferable but not mandatory – practical experience in:
o List A / B products
o Analytical performance characteristics (CLSI, ISO 18113-1)
o Clinical performance evaluation
o CDx development
· Experience in IVD/medical device industry, preferably in regulatory affairs and/or quality management related positions and/or Notified Body experience is of great advantage
· Being a team player is a must
· Excellent project management skills
· Good written and oral communication skills in English and German
Are you interested?
This is full time job. If you possess above mentioned skills please send your application including cover letter, curriculum vitae and references to our human resources team at firstname.lastname@example.org
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