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

About the role

The specialist will ensure compliance with quality and regulatory requirements across the product lifecycle, handling complaints, field actions, CAPAs, product releases and training programs. The role also includes maintaining product registrations and supporting launches.

Key responsibilities

• Act as Local Complaint Coordinator, notifying authorities of reportable complaints.
• Manage field actions, ensuring implementation according to Baxter procedures and regulations.
• Train employees, distributors, suppliers and service providers on Baxter requirements and maintain training records.
• Handle non‑conformity reports and corrective‑preventive actions (CAPA).
• Perform product release for distribution and selling authorization for Turkey.
• Develop and execute regulatory plans, coordinate submissions and maintain product registrations throughout the lifecycle.

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 English communication skills, both spoken and written.
• Ability to work independently and cross‑functionally.

Required skills

• GMP, GDP, ISO 9001, ISO 13485 knowledge.
• Regulatory submission and documentation management.
• Microsoft Office suite (Word, Excel, PowerPoint, Outlook).
• Corporate software proficiency.