Medical Device Regulatory Expert
2 weeks ago
We are seeking a seasoned Medical Device Regulatory Expert to join our team at Bioeksen R&D Technologies Inc. The successful candidate will be responsible for ensuring compliance with global regulatory requirements, including EU IVDR, FDA, and ANVISA regulations.
About the RoleIn this role, you will work closely with cross-functional teams to integrate regulatory requirements into product development and commercialization processes. You will 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. Excellent written and verbal communication skills in both Turkish and English are essential for success in this role.
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.
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