Regulatory Affairs & Quality Assurance Specialist

Randstad Türkiye

On behalf of our global partner operating in the medical device sector, we are looking for a"Regulatory Affairs & Quality Assurance Specialist" to join their growing team.

Job Description;

• Support the preparation, compilation, and submission of regulatory applications (new, existing, and variation) to obtain and maintain product registrations inÜTS,
• Manage distributor registrations and updates within the ÜTS platform,
• Manage reimbursement applications and processes in line with SUT requirements,
• Monitor regulatory developments from local and international authorities; proactively communicate relevant updates to internal stakeholders and support the timely implementation of required actions.
• Handle product complaints in accordance with company procedures and Ministry of Health requirements (EBS system), ensuring timely reporting and follow-up,
• Ensure all product complaint investigations are conducted thoroughly, with comprehensive investigation reports delivered to customers within defined timelines,
• Communicate effectively with external stakeholders, including regulatory authorities, notified bodies, and industry partners, ensuring compliance and alignment,
• Collaborate and maintain close alignment with the RA Department at Global HQ.
• Ensure strict compliance in warehouse and logistics operations, including proper storage conditions, handling, and distribution of medical devices,
• Monitor and control warehouse quality processes, including temperature/humidity tracking and documentation accuracy to ensure product integrity,
• Support internal, external, and regulatory/official audits.      

General Qualifications

• Bachelor’s degree in Biomedical Engineering, Chemical/Biological Engineering, Pharmacy, or other related disciplines,
• Minimum 3-5 years of experience in Regulatory Affairs (RA) and Quality Assurance (QA) within the Medical Device industry,
• Advanced knowledge of ÜTS (Product Tracking System) and EBS (Electronic Application System) processes,
• Strong command of SUT (Health Implementation Communiqué) regulations and hands-on experience in reimbursement applications,
• Knowledge of Medical Device Regulation (MDR) and ISO 13485 Quality Management System standards,
• Excellent command of written and spoken English (capable of managing communications and coordination with Global HQ),
• Detail-oriented, analytical thinker with strong follow-up skills,
• Strong communication skills with the ability to maintain professional relationships with government authorities and international stakeholders.