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Regulatory Affiars ( FDA Product Registration Officer )

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CompanyConcordia International
Industry
Manufacturing
No of Employees
51-100
Website
https://sites.google.com/site/concordiamyanmar/
Company description

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Concordia International Limited we first incorporated in Myanmar in 1994 to provide sales of Engineering & Medical Equipment, Material Testing Equipment, Environmental Testing Equipment, Laboratory Equipment, Multimedia Equipment and the main activities have developed into import, distribution, technical support, after sales service and maintenance of these products in various specialties.

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Job description
Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
Complete submissions to Myanmar FDA regulatory entities
Create and maintain product technical files.
Review advertising and marketing material for appropriateness and compliance to
regulatory requirements and laws.
ensure re-validation of products before expiry dates
FDA process will be fully trained
Other duties as assign





Desired Skills and Expertise
Requires a degree in a science or related field
no prior experience within the regulatory affairs discipline is needed
Knowledge of international medical device regulatory requirements- is a plus
Experience with Class II devices is mandatory International experience is a plus

Language skills

We offer Male / Female
Salary is negotiableWe might provide you with accommodation

Work location Mict Park New Building, Yangon
State/District: Yangon Region

More information Industry: +Other
Job Function:
Employment Type: Other
Full time: YES
Job posted: 12/11/2016

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Concordia International

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Concordia International

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-

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Concordia International

-

-

Concordia International Limited we first incorporated in Myanmar in 1994 to provide sales of Engineering & Medical Equipment, Material Testing Equipment, Environmental Testing Equipment, Laboratory Equipment, Multimedia Equipment and the main activities have developed into import, distribution, technical support, after sales service and maintenance of these products in various specialties.

-

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