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RA Egineer at ZEISS Group

Guangzhou City, Guangdong Province, China -

Full Time

Start Date

Immediate

Expiry Date

22 Mar, 26

Salary

0.0

Posted On

22 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Devices, NMPA Regulations, Clinical Evaluation, Communication, Problem Solving, Team Collaboration, Documentation, Product Registration, Expert Communication, Approval Process, Change Management, Bilingual, Eye Care Devices, Compliance, Testing Procedures

Industry

Machinery Manufacturing

Description

5年国产三类医疗器械RA工作经验，具有眼科医疗器械注册经验优先。熟练掌握NMPA医疗器械相关法规、标准和指导原则，能够准确解读法规要求。三类医疗器械注册申报和获批经验: 能够熟练起草注册申报资料，协助编写临床评价报告，确保资料真实且合规; 能够熟练开展与审评专家的沟通，跟进审批进展，协调解决审评问题。三类医疗器械注册检测和委托检测经验：熟悉产品注册和委托检测相关流程和要求，能够熟练与检测中心专家沟通，跟进检测进展，并高效解决检测问题。三类医疗器械复杂变更注册经验。良好的跨部门协作能力和良好的团队合作精神。可作为工作语言的中、英文听说读写能力。无 Your ZEISS Recruiting Team Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together. Join us today. Inspire people tomorrow. Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity. Apply now! It takes less than 10 minutes.

Responsibilities

The RA Engineer will be responsible for drafting registration application materials and assisting in the preparation of clinical evaluation reports. They will also communicate with review experts and coordinate the approval process.