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