北京招聘

Job Title: Compliance Specialist
Reports To: Senior Manager, Compliance
Group/Division: China Technology Center /
Position Location: Shanghai
Replacement/ New Add: New Add


Division/Business Unit Summary:
Regulatory Affairs team is responsible for providing professional support in regulatory needs of business growth, ensuring products sold in China and relevant business are in accordance with China regulations. Main responsibilities in getting product premarket approval and post market surveillance.
Position Summary:
Ensuring all imported medical product sold in China are in accordance with China regulations.
Update regulatory status of all products in SAP.
Work with supply chain on product regulatory check for release.

Key Responsibilities:
Maintain and modify system of product regulatory status bases on China regulations on IVD , medical devices and danger goods.
Update supply chain and business departments of any changes of regulatory requirements.
Communicate with overseas facilities about China requirements.
Support RA team other works

Qualifications Required:
Bachelor degree.
No less than 4 years work experiences, at least 2 years in quality system or compliance in medical device industry.
2 years work experiences in multinational company is preferred.
Familiar with SFDA regulations on MD/IVD, especially on MD distribution management and Chinese labels.
Work with accuracy and carefulness.
Take challenge and willingly to learn.
Good communication skill cross function.
Fluency in English

Desired:

Compliance work experience in medical devices


If you have an interest in this opportunity, please send your CV to celia.wu@eagleconsulting.cn

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