Medical devices certification manager

We are currently looking for CE IVD Managers.


Job description

• Ensure certification and registration of in vitro diagnostic devices (IVD) within the EU regulations
• Ensure certification and registration on the non-EU markets
• Analyze and manage requests from regional authorities for certain regions
• Responsibility for management and preparation of necessary documentation within the company
• Represent company in negotiations with Notified Bodies (NB) or other local authorities
• Take part in certification audits of NB or other authorities
• Cooperate with other departments within the company
• In the future – FDA certification and WHO prequalification


Candidate profile

• University degree in biology, pharmacy or biochemistry
• Advanced knowledge of IVD registration, IVD EU regulation business and ISO 13485
• Active use of English (minimum level B2), another language is an advantage
• Multi-year experience with IVD, knowledge of FDA, WHO or other local authorities is an advantage

• Open for candidates with disabilities
• Not suitable for graduates
• Suitable also for foreign candidates


We offer

• Work experience in a growing Czech biotechnological company
• Friendly work environment in a young team
• Top-equipped laboratories
• Interesting and motivating salary
• Mobile phone
• Language courses
• Support of further education, training and courses
• Sick days
• Refreshment at workplace
• Meal tickets/ eating options close to workplace
• Job location - Brno
• Immediate start possible


Please send your CV and letter of motivation in Czech and English to Please enter „Medical devices certification manager" into the Subject field.
Thank you for your interest in the Geneproof a.s. company.
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