Write and review new product and change submission dossiers for Cook Medical's products in Thailand.
Preparation and submission of additional licenses with Thai FDA such as License per Import and Special Access License.
Negotiate with local authorities on behalf of Company objectives.
Act as the key person to communicate and negotiate with local regulatory authorities.
Understand and maintain database and systems used for regulatory controls and submission work.
Create and maintain training materials to improve awareness on Thailand regulatory landscape.
Keep up with Thailand regulatory requirements and inform relevant internal parties in a timely manner.
Update Cook Medical manufacturers and key stakeholders of any changes in local regulatory requirements.

Degree in Science, Engineering or other related discipline.
At least 3 years working experience in regulatory field for medical device or pharmaceutical industry.
Experience in regulatory submission work and negotiation with regulatory authorities.
Excellent communication and interpersonal skills.
Excellent time management and organizational skills.
Fluent in English and Thai (both spoken and written).
High level of computer skills including Microsoft Office.
Skilled in document management, able to multi-task and prioritize tasks.

Regulatory Affairs Specialist

Key skills