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Recruit Ref: L049833495
Posting Date: 2022-12-01
Sanwa Biotech Limited
Sanwa Biotech Limited

Sanwa BioTech delivers accurate and actionable diagnostic information through our Point-Of-Care(POC) platform and BioChip. It combines Lab-On-Chip and Microarray technologies resulting in transformative diagnostics for faster clinical decisions. We formed basis for this concept of bringing forth a multi-target POC solution for diagnosis of time critical and life-threatening diseases.

For more details, please visit https://www.aliabiotech.com/

Regulatory Affairs Officer/ Associate

Job Duty:

  • Provide support for regulatory affairs related issues to ensure compliance with global regulatory requirement.
  • Prepare technical documentation in support for regulatory submissions.
  • Provide update and maintain status of product registrations and notification.
  • Facilitate/ responsible for the communication with CROs or hospitals.
  • Monitoring progress throughout the duration of clinical study.

Requirement:

  • Degree or above in Life Sciences or medical sciences discipline
  • Solid knowledge in microbiology/ immunology/ biochemistry or any of science discipline preferred
  • Experience in ISO 13485 is preferred
  • Experience in medical device / in vitro diagnostics regulatory submissions such CE, PMA, 510(k), NMPA submission is a plus
  • Experience with clinical trials/ clinical studies is a plus
  • Responsible, independent with strong problem-solving skills, excellent interpersonal communication skills and team spirit is highly preferred
  • Fluent in in English, Cantonese, and Mandarin
  • Good written English and Chinese
  • Candidates with less experience will be considered for the post of Regulatory Affairs Associate

 We offer an attractive remuneration package including competitive salary, 5-day work, annual leave and medical insurance.  If you are interested in this career opportunity, please apply with your detailed resume, present and expected salary by clicking hr@sanwabiotech.com

Personal data collected will be used for recruitment purpose only.


Summary
Industry:
Information Technology 
Job Position Level:
General 
Employment Term:
Full Time / Permanent 
Min. Edu. Level Req:
Bachelor 
Minimum QF Level attained:
-- 
Total Working Exp:
-- 
Salary(HKD):
--
Location:
Shatin District
Benefits:
  • Five-Day Work
  • Medical Insurance
  • Performance Bonus
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