Product Safety (Senior) Manager, Medical Device, Listed in NYSE
Pioneer medical device company listed in NYSE
Regional exposure for Asia Pacific
About Our Client
Our Client is a leading medical device company. Their goal is to improve our patients¡¯ quality of life by introducing innovative technologies and treatment concepts. Due to the market demand, they are looking for a Product Safety (Senior) Manager to join their organization.
Our client is currently recruiting a Product Safety (Senior) Manager responsible for providing precise and accurate product safety related activities for the medical device in compliance with regulations and policies.
The duties include:
Collect, review, process and prepare of notifications to authorities and government bodies relating to AE/incidents or risk associated with their products;
Closely monitor and interact with product safety associates in order to supervise and follow up the region¡¯s product safety activities to ensure it follows its region¡¯s level;
Supervise post approval compliance activities: PSUR, PMSS, Literature Screening and other safety related data submission according to approval requirements, support inquiry from national authority;
Responsible for Product recall and related exercises such as Field Safety Corrective Action (FSCA).
The Successful Applicant
The successful candidate will have experience working in medical device or pharmaceutical company:
Qualifications: Bachelor or above in Biomedical, Life science, Engineering or other related disciplines;
6 years+ relevant working experience related to pharmacovigilance (PV) or medical devices vigilance;
Strong technical experience in QA/QC/RA in medical device/ pharmaceutical industry;
Experience in Risk Management system is a plus;
Knowledge of regulations and compliance to safety issue among devices and drugs.
What's on Offer
Your commitment and passion to drive the operation will be rewarded with a highly lucrative remuneration package including attractive 13 months guarantee salary plus performance bonus. Operating within a dynamic and friendly environment, substantial resources will be provided in support of the delivery of your duties.