– Ensures regulatory compliance of medical devices with regulations on country level and in country of delivery and executes all required regulatory activities.
– Responsibility for coordination and preparation of regulatory product notifications and registrations in given timelines.
– Contact with State Institute for Drug Control and Slovak Chamber of Commerce and Industry to register new medical products or update existing registrations.
– Preparation and update of technical files and internal documents.
– SK-EN translation of required documentation.
– Preparation and maintain of regulatory documents (declarations, summary reports, clinical evaluation, summary of relevant web search etc.) required for marketing approvals in different countries.
– Legalization of documentation and certificates via notary offices, embassies and Ministry of Foreign Affairs as necessary to obtain and sustain product approval.
– Supporting registration of customers in international markets.
– Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
– Decomposition of products in connection with exports and ensuring Certificate of Country of Origin.

We offer:
– Contract for indefinite duration
– Opportunity to be part of a strong and stable international company
– Professional education and continuous gaining of new experience
– Meal vouchers € 4.80

If you are interested in this position, please send us your CV in English language. We will contact suitable candidates only. Thank you for your understanding.

Please note that together with your application for employment, you are granting us your consent to the registration and processing of personal data under Act No 18/2018 Z.z. and Regulation (EU) 2016/679.