Sr. RA Specialist

Primary Function of Position

The position is responsible for the product registration strategies set up and execution of them.

This position is also responsible for new product approvals and maintenance of the approved product licenses via timely renewals, re-registrations.



Essential Job Duties

• Product registration

o Understand regulatory requirements and medical device regulations.

o Spearhead all procedures of product registration, amendment, and administrative work precisely and efficiently, including planning, compiling registration submission, filing documents related and data archiving, reports, etc.

o Provide input on the product registration status and results to function head as well as stakeholders within ISI & IST to help their planning and business of the company.

o Assess the product changes and develop regulator...

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