Regulatory officer

Regulatory Officer (18-35K) (SDG-28136)
<Job Responsibilities>
Responsible for all regulatory affairs, regulatory compliance activities and submission of registration of medical device of the company.
Key Responsibilities
Review the Certificate of Free Sale (CFS)
Prepare submissions to Thai FDA
Notify and update Thai FDA of any change of particulars or documents related to product registration.
Maintain and archive MSDS document
Coordinate with related parties to manage pharmacy registration
Coordinate with related parties to manage Medical Device Registration
Update FSC document
Maintain the knowledge and awareness of current applicable regulations and standards also the latest news of importing medical device
Performs other duties as assigned
Expected Result
Be able to manage regulatory procedures and submission of product registration to FDA for approval
Knowledgeable in Thai regulations




<Necessary Skill / Experience >
Thai nationality, Male/Female, age 24-30 years old
Bachelor's degree in Science or related field
At least 1 year experience in regulatory affairs, responsible for Medical Device Registration
Good command of written and spoken English.
Good computer skills (Microsoft office)
Work well under pressure
Good communication skills
Be able to manage work effectively and has high responsibility

<Preferable Skill / Experience>
None


Languages skills
English: Conversational Level
Japanese: None


Workplace Area: Bangkapi, Bangkok
Working Hour: 8:30-17:00(Mon-Fri)


About the Benefits
Salary: 18,000–35,000THB



About the company
Products: Dental supplies
Business Type: Medical Equipment

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