Your main responsibilities
Create and maintain product documentation required for registrations
Initiate, manage, and successfully complete regulatory registration processes for new products
Register new products on the European market (EUDAMED) and ensure timely updates of documentation for products already on the market
Support our distributors outside the EU in their product registration processes
Handle daily administrative tasks related to trade and registrations
Provide partners with the necessary product certificates (Declaration of Conformity, Free Sales Certificate, IFU, MSDS, etc.)
Liaise with distributors, notaries, embassies, relevant ministries, the Hungarian Chamber of Civil Law Notaries, and the Hungarian Chamber of Commerce and Industry
Participate in post-market surveillance processes
Requirements
- Strong command of Hungarian (written and spoken)
Strong command of English (written and spoken) and ability to maintain official documentation in English
Proficiency in MS Office tools
Ability to work independently and systematically, with strong analytical skills, reliability, and a proactive attitude
Relevant professional experience in a similar field is essential
Nice to have
Experience in medical devices or laboratory diagnostic instruments
Knowledge of IVDR regulations and ISO 13485 quality management systems
Experience in supporting and conducting clinical performance evaluations
Familiarity with technical and medical device standards
What we offer
Competitive salary and cafeteria allowance
One day/week remote work
Modern, professional work environment
40-hour work week
If our job posting has caught your interest, please send your professional CV, including your net salary expectation, to beata.andrasi@normadiagnostika.com.
