Tuyển Sales Manager thu nhập Thương lượng tại Hà Nội - Công Ty TNHH Chuyển Giao Công Nghệ Và Dịch Vụ Y Tế

About the Role:
We are seeking a qualified PRRC to join our team and oversee technical documentation for CE marking under the Medical Device Regulation (MDR). This role will involve managing and maintaining the regulatory documentation for multiple Class IIa and IIb medical devices, ensuring ongoing compliance with EU MDR requirements.
Key Responsibilities:
• Oversee the creation and updates of essential regulatory documents including CEP, CER, and PMCF Reports.
• Conduct literature reviews and perform benefit/risk calculations for Clinical Evaluation Reports (CER).
• Manage Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) activities, including the development and maintenance of Plans and Reports.
• Maintain and update the Risk Management file, Usability Engineering file, and Biological Safety Evaluation.
• Verify content of Instructions for Use (IFU) to ensure compliance with MDR requirements.
• Coordinate and manage regulatory updates and potential changes to SOPs.
• Serve as lead auditor for internal audits, including the preparation and execution of internal audit reports.
• Provide assistance with NB (Notified Body) auditors’ queries and non-conformities during external audits.

Ứng viên nộp hồ sơ trực tuyến bằng cách bấm Ứng tuyển ngay dưới đây.

Hạn nộp hồ sơ: 09/04/2025

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