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SHD Post Market Surveillance Specialist

Job Description

Responsibilities

PMS Specialist will handle below responsibilities focused on FSCA (recall) and AE (Adverse Event):

1. FSCA review and evaluation together with MKT, Monitor FSCA reporting process to ensure all reporting is done according to relevant regulation in time.

2. Monitor AE reporting process to ensure all reporting is done according to relevant regulation in time.

3. Receive the AE from oversea country, review and submit the AE data to China Authority. Follow up the process based on the timeline requirement.

4. Support RA during product renewal on product FSCA and AE related documentation and clarification. 

5. Keep a close communication with MKT, sales, CS, RA and other department.

Requirements:

1. At least 1-2 years quality, label, post-market survilliance related experience. Fresh graduate with high potential is also welcomed. 

2. Bachelor degree or above, major in medical, bitotech or pharmaceutial preferred

3. Be familiar with medical device/diagnositc industry and related regulation

4. Experience on commercial product quality including labeling, post-market supervision etc, regulatory experience preferred

5. Patient and careful in nature, strong responsibility and flexibility in daily work

6. Good written and oral English, CET-6 preferred



Organization: Siemens Healthineers

Company: Siemens Healthineers Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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