Assistant Regulatory Affairs Manager - APAC
HK$35,000 - HK$45,000
About Our Client
Our client is a US listed Medical Device company specialized in radiation therapy for oncology
- Write, analyze, and manage regulatory applications submission approvals in APAC.
- Evaluate New Product Introduction (NPI) projects and develop regulatory strategies
- Ensure research and clinical evaluation are in compliance with necessary regulatory requirements.
- Prepare Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc.
- Support Post Market Surveillance activities e.g. FSCA, MDR, etc.
The Successful Applicant
- Bachelor's Degree in Bio-medical Engineering, or related discipline
- 3 years + experience in Regulatory Affairs (medical device), pharmaceutical background will also be consider.
- RA experience in APAC
What's on Offer
- Attractive salary
- Stable career
- Regional exposure