Regulatory Affairs Coordinator – Biometrix, s. r. o.
Miesto práce: Vicenzy 16, Šamorín
1 300 EUR/monthbased on experience
Information about the position
Job description, responsibilities and duties
– 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.
Employee perks, benefits
– 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
Information about the selection process
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.
Requirements for the employee
Candidates with education suit the position
Number of years of experience
Personality requirements and skills
High attention to details.
Strong analytical and organizational skills.
Strong writing skills.
Strong interpersonal skills.
Brief description of the company
Biometrix is part of Q Medical Devices, a Q Holding Company, which is owned by 3i.
Number of employees
931 01 Šamorín