Quality & Regulatory Support Coordinator(Temporary

BECKMAN COULTER BİYOMEDİKAL ÜRÜN.SAN.VETİC.LTD.ŞTİ

Key Responsibilities

Support QA/RA Team for Quality and Regulatory Affairs activities.

Quality Activities:

·   Process all types Customer Feedbacks; conduct translation, assign to the investigators, analysis and    appropriate support to the users.

·   Monitor the investigation and completion.

·   Send reminders to action responsible person in internal/ external audit findings.

·   Support QA/RA, Turkey – as needed for local quality documentation, projects, other Quality subjects     etc.

Regulatory Affairs activities

·   Support product registration activities:

Ø  Preparation / translation check of registration files to be submitted to Ministry of Health:

Ø  Preparation of Turkish labels

Ø  Preparation of product photos

 ·   Update and maintain the product registration database

 ·   Support post market activities(distribute the customer letters, follow up on the response  forms, report to CA when applicable following MEDDEV 2.12-1 and current BC procedures in place)

Knowledge/Competencies and Behaviour

• 0-2 years experience
• Fluent in English – written and verbal
• University Degree in Science or equivalent
• Previous  experience in the medical device industry is an asses
• Knowledge of Quality Standards including ISO 9001 and ISO 13485 Quality Management Systems and Previous  experience in Regulatory Affairs IVD / medical devices is an asset
• Ability to prioritize and handle multiple tasks: analysis, judgments and flexibility
• Good communication skills and team player
• At ease with IT tools and MS office – At ease with statistical tools/reports is an asset