Regulatory Affairs Specialist

1 week ago


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

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Bioeksen R&D Technologies Inc.

About the Role

The successful candidate will be responsible for ensuring compliance with global regulatory requirements, including EU IVDR, FDA, and ANVISA regulations. They will work closely with cross-functional teams to integrate regulatory requirements into product development and commercialization processes.

  • Maintain up-to-date knowledge of regulatory requirements and ensure that all documentation is compliant.
  • Prepare, review, and submit regulatory documentation for new product registrations, renewals, and amendments in accordance with global and local regulations.
  • Collaborate with the Quality Assurance team to ensure the QMS meets regulatory requirements.

The ideal candidate will have a strong understanding of regulatory project management and a thorough knowledge of global regulatory requirements. They will also possess excellent written and verbal communication skills in both Turkish and English.

Key Responsibilities

Regulatory Submissions and Documentation:

  • Prepare and submit regulatory documentation for new product registrations, renewals, and amendments in accordance with global and local regulations.
  • Maintain up-to-date knowledge of regulatory requirements and ensure that all documentation is compliant.

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.

Quality Management System (QMS):

  • Collaborate with the Quality Assurance team to ensure the QMS meets regulatory requirements.
  • Support internal and external audits related to regulatory compliance.


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