Regulatory Affairs Specialist

2 weeks ago


Gurgaon, India ALTEN India Full time
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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