Senior QARA Specialist

Industry: Medical Devices
Job Type: Full Time
Experience level: Specialist
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The Senior QARA Specialist will be entrusted with spearheading the Commercial Quality and Regulatory Affairs function within our organization. The role involves ensuring that our products and processes meet and exceed regulatory standards while upholding the highest levels of quality and compliance.

The Senior QARA Specialist role is based in Istanbul, Turkey.


  • Senior QARA Specialist will be responsible for maintaining continuous alignment of Quality Assurance and Regulatory Affairs (QARA) standards in our distribution centers and processes within the assigned area. This includes oversight of both in-house operations and third-party warehouse and logistics centers.
  • Oversee and manage the Quality Management System (QMS) to ensure compliance with relevant regulations and standards.
  • Provide support to supply chain and distribution activities, ensuring adherence to quality and regulatory requirements throughout the process.
  • Apply in-depth knowledge of local regulatory requirements and relevant quality systems to ensure compliance in all operations.

Qualifications & Skills

  • Demonstrated experience in conducting internal and supplier audits as required by regulatory standards.
  • Ability to interact with and liaise with Competent Authorities as part of field action, vigilance, and post-market surveillance activities.
  • Proficient in the English language with strong communication skills, both written and verbal.
  • Experience in answering technical and regulatory inquiries from customers and/or colleagues to support their business activities.

Senior QARA Specialist - Istanbul, Turkey - Agnieszka Bednarz

DNA consultant in charge of this requisition:

Agnieszka Bednarz

CEEMEA Senior Research Consultant

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