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Regulatory Affairs Specialist
1 week ago
JOB DESCRIPTION:
Essential duties & responsibilities:
Coordinate with Division contact to get the essential documents
requested by Taiwan RAQA on time during Taiwan registration process (including Taiwan license application and QSD application).
Establish and maintain a good working relationship with Taiwan RA/Division peers to gain positive & timely support for document preparationEducation & special trainings:
At least Bachelor's degree holder, healthcare/medical/engineering related major is preferred but not limited toBasic understating about ISO 13485 and US FDA regulation (Medical Device Related)
Qualifications & experience:
Relevant regulatory and quality assurance experiences in international company for 2 years
Physical & mental requirements:
Detailed oriented.
Excellent communication skillsAbility to move others to take action.
Hands-on ability to implement swiftly and effectively by taking ownership and accepting responsibility.
High ethical standards and integrity.
Well-organized and logical thinking.
Good at planning processes, patient and a great sense of responsibility.
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