Global Regulatory Compliance Professional

1 week ago


Fatih, Istanbul, Turkey Bioeksen R&D Technologies Inc. Full time
Job Overview

Bioeksen R&D Technologies Inc. is seeking a talented Global Regulatory Compliance Professional to join our team. As a key member of our organization, you will play a critical role in ensuring our medical devices meet the highest standards of quality and regulatory compliance.

About the Job

In this role, you will be responsible for managing regulatory projects from initiation to completion, ensuring timely delivery of regulatory milestones. You will work closely with cross-functional teams to integrate regulatory requirements into product development and commercialization processes.

  • Develop and maintain project plans, timelines, and status reports.
  • Collaborate with the Quality Assurance team to ensure the QMS meets regulatory requirements.

You will possess a strong understanding of regulatory project management and a thorough knowledge of global regulatory requirements. Excellent written and verbal communication skills in both Turkish and English are essential for success in this role.

Responsibilities

Regulatory Project Management:

  • Manage regulatory projects from initiation to completion, ensuring timely delivery of regulatory milestones.
  • Develop and maintain project plans, timelines, and status reports.

Compliance and Risk Management:

  • Ensure products comply with relevant regulatory standards and guidelines throughout their lifecycle.
  • Conduct risk assessments and implement mitigation strategies as part of the regulatory compliance process.


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