Regulatory Affairs Specialist

Alvimedica Tıbbi Ürünler San. ve Dış Tic. A.Ş.

We are looking for a Regulatory Affairs Specialist having the following qualifications to be employed in our factory located in ÇATALCA.

·         Min. B.Sc. degree, preferably master's degree (Business Administration / Chemistry / Engineering, Biology, etc. relevant departments)

·         Minimum 3-4 years experience on RA, Quality, Marketing or Sales preferably in Medical Sector

·         Fluent in English

·         Strong communication skills, negotiation techniques

·         Planning, organization and coordination skills

İŞ TANIMI

·         Prepare the submission files for country registrations (including CE Design dossiers according to MDD 93/42/EEC)

·         Prepare the application dossiers of products for Undersecretaries of Foreign Trade

·         Prepare the application dossiers for reimbursement

·         Communicate with the distributor and/or the agencies for product registrations in required countries

·         Follow the agreements related with the registrations, signed with the distributors or agencies and achieving these agreements

·         Follow the updated country regulations and design country registrations accordingly