Regulatory Affairs Specialist
1 week ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Bioeksen R&D Technologies Inc.
About the RoleThe 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 ResponsibilitiesRegulatory 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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