Regulatory Affairs Specialist

Regulatory Affairs Specialist (30K-50K) (SDG-27853)
<Job Responsibilities>
Responsible for all regulatory affairs, regulatory compliance activities and submission of registration of medical device of the company
Gain and maintain optimal regulatory approvals in a timely manner and in compliance with relevant regulations
Review and update information, labels and other documentation as required for regulatory compliance
Maintain and track the import licenses’ validity of all marketed products
Build constructive relationships with local regulatory representatives and local health authorities, as required and maintain an awareness of new legislation, policies and guidelines of local health authorities impacting the company
Responsible in reporting to local health authorities regarding Field and Safety Corrective
Action and Adverse Event and maintain its database
Provide regulatory inputs and support for marketing plans, product registration and variations to the marketed products
Safe keeps confidential records and maintain all regulatory databases and report to regional RA supervisor in a timely manner



<Necessary Skill / Experience >
Thai nationality, Male/ Female, age 24 – 40 years old
Bachelor’s degree
At least 1 year working experience in hospital or knowing about medical device
English : Conversational high (reading&writing, To coordinate with Singapore-Headquarter)

<Preferable Skill / Experience>
Academic background of Medical Technologist

Languages skills
English: Conversational Level
Japanese: None


Workplace Area: BTS Pleonchit Station, Bangkok
Working Hour: 8:00-17:00 (Mon-Fri)

About the Benefits
Salary: 30,000–50,000THB

About the company
Products: Selling and distributing of Medical Devices, Robotic Surgical Equipment
Business Type: Medical Equipment

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