REGULATORY AFFAIRS OFFICER

JOB SUMMARY:

Responsible for the preparation and submission of initial or renewal registrations and variation documents of medical device products in Philippine FDA.Handle customer queries and coordinates request to ensure they are met and provided in an efficient manner.Perform activities for getting new registrations and maintaining registrations as per business goals.

QUALIFICATION:

Graduate of BS Pharmacy, BS Chemical Engineering, Medical Science. or any allied courses.Preferably with at least two (2) years work experience.Knowledgeable in Device Labelling, Design Control, Risk Management, CSDT, Technical documentation and MS Office Applications.

A subsidiary of Terumo Corporation, the “No. 1 Medical Device Manufacturer in Japan” with 20 factories and 79 sales branches supplying 150 countries globally. With the mission of contributing to society through healthcare, we produce our innovative products with strict quality assurance system and vast technological expertise and we develop our employees with this “Global Competitiveness”.