Compliance

• Compile and collate documentation and technical product files necessary for the market authorization, registration and reimbursement of the assigned product assortment (Medical Device and Cosmetics).
• Ensure that all documents and processes are in accordance with internal regulatory and quality procedures as well as applicable national laws and regulations.
• Maintain product records and regulatory information in applicable Ministry of Health systems, including UTS and other regulatory platforms.
• Support compliance activities associated with Economic Operator obligations, product traceability requirements and post-market regulatory obligations.
• Establish and maintain a project chart and an authorization overview for registration and reimbursement submissions.
• Monitor changes in healthcare, medical device and reimbursement regulations and communicate impacts to relevant stakeholders.
• Provide input to support processes related to regulatory, quality, reimbursement and compliance.
• Assist in Document Control & Change Control activities.
• Support the commercial team in collecting and preparing documentation required for tender submissions.
• Support and facilitate healthcare compliance reviews, including Independent Decision Making Process (IDMP).

Regulatory Affairs and Compliance Specialist

• Execute regulatory submissions (registrations, variations, renewals) and support product lifecycle management
• Ensure compliance with local regulations, GxP standards, and company SOPs; maintain inspection-ready documentation
• Support audit and inspection readiness, including responses to Health Authority queries and CAPA tracking
• Maintain regulatory documentation and manage data in regulatory and quality systems
• Monitor regulatory changes and support implementation across the portfolio
• Collaborate cross-functionally (Medical, Safety, Quality, Supply Chain) to ensure compliance and supply continuity

Regulatory Affairs & Compliance Specialist

• ICS kontrollerini uygulamak ve yürütmek, kontrolleri gerçekleştirmek, açıkları belirlemek ve bunların çözülmesine destek vererek mevzuata ve iç gereksinimlere uyumu sağlamak.
• AEO Yıllık Faaliyet Raporu sürecinden sorumlu, doğru veri analizi, konsolidasyonu ve bulguların doğrulanması; düzeltici işlemleri takip etme ve süreç iyileştirmenin sağlanması.
• Gümrük değeri ile ilgili maliyetlerin beyanını yapmak ve Vergi ve Muhasebe departmanlarıyla koordinasyon sağlamak.
• Gümrük ve diğer ilgili mevzuatlardaki değişiklikleri günlük olarak izlemek, bunların şirket süreçleri üzerindeki etkilerini analiz etmek ve gerekli tedbirleri almak.

Compliance jobs in Turkey

See all jobs on JobTailor

Regulatory Affairs and Compliance Specialist

Regulatory Affairs & Compliance Specialist

Senior Customs Compliance Control Specialist