Ruhsatlandırma Uzmanı

T-Biyoteknoloji

Requirements & Responsibilities

• Bachelors Graduate Degree (Preferably from a Science Degree)

• Experienced at least 4-5 years in the field of Regulatory of Medical Devices and/or Drug and/or Drug-Device Combinations (CE Classification of IIa, IIb, III)  
• Highly skilled in QMS and ISO 13485
• Advanced Level of English Skills (Fluent in English, Terminology etc.)
• Advanced Level of MS Office Programs
• Result-Oriented
• Excellence in teamwork skills 
• Effective communication skills 
• Persuasion, Negotiation and Cooperation skills. 
• For Male Candidates, Military service must be completed.

Job Description

• Preparing and follow-up the CE (i.e. Technical Construction Files, Design Dossiers) files for authorization and registering the medical device(s).
• Contact with related departments to receive necessary information and/or documents.
• Processes and policies to be improved, applied and maintained to meet the law/directive(s) and company needs.
• Keep the records and secure all data related to the system(s) and product(s) 
• Follow-Up timing for constructing the medical device file.
• Coordinating the other departments when and where necessary.
• Performance testings and follow-ups also in coordination with other departments.
• Regarding regulatory compliances and activities, ensuring all data and actions are taken legally according to the authorities, laws, directives etc.     
• Follow up all supportive documents and secure the updated versions.