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 info@geneproof.com. 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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