Quality Assurance and Regulatory Affairs Specialist (12‑month Fixed‑Term)

About the role

The Quality Assurance and Regulatory Affairs Specialist will ensure compliance with quality and regulatory requirements across the product lifecycle. This 12‑month fixed‑term position supports complaint handling, field actions, CAPA management, product releases and regulatory submissions for the Turkish market.

Key responsibilities

• Act as Local Complaint Coordinator, notifying authorities of reportable complaints.
• Manage field actions, ensuring implementation according to Baxter procedures and regulations.
• Coordinate training for employees, distributors, suppliers and service providers on Baxter requirements.
• Oversee Non‑Conformity Reports and CAPA processes.
• Perform product release for distribution and manage selling authorizations in Turkey.
• Develop and execute regulatory plans, maintain product registrations and support product launches.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry or Chemical Engineering (preferred).
• Minimum 2 years of experience in Quality Assurance and/or Regulatory Affairs within pharmaceutical or medical device industry.
• Knowledge of GMP, GDP, ISO 9001 and ISO 13485 (preferred).
• Strong written and spoken English.

Required skills

• GMP and GDP knowledge.
• Familiarity with ISO 9001 and ISO 13485 standards.
• Proficiency in Microsoft Word, Excel, PowerPoint and Outlook.