J o b P r o f i l e |
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Status : |
Ongoing |
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Date: |
2011-04-18 |
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B a s i c D a t a |
Business Unit |
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Name of Function |
RA Specialist |
Corporate Key Function |
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Title |
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Location |
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Corporate |
Division/Group |
Division/Group-Corporate |
Division/Group-Sales Regions |
Regions |
Customers/Partner/Associations |
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Product Business |
System Business |
Mission of Function |
Regulatory affairs specialist pay critical roles throughout the ultrasound product lifecycle. He/she may work with internal & international project team and provide advice & counsel to stakeholders and perform a country registration to deliver the safe and effective ultrasound products to worldwide within regulations |
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T a s k s |
A r e a s o f R e s p o n s i b i l i t y / T a s k s |
What - How - Why |
- [Country registration for Korean and other countries] Prepare submission package and submit to KFDA and regional RA specialist / Communicate the response from government / Maintain records on legislation, regulations, guidelines and regulatory files for each country / Update and maintain paper/electronic document archival systems - Assist product type test in Korean test laboratories - Assist quality & regulatory inspection such as ISO13485, KGMP, QMS, FDA, ANVISA and etc - Assist the preparation of postmarket reports and submissions such as recall, adverse event report and complaint - Provide regulatory input to product lifecycle planning and communicate regulatory information to stake holders |
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C o m p e t e n c i e s |
K n o w l e d g e |
Techniques (Technologies / Methodologies / Professional Knowledge) |
- English communication skill - MS office Skill - Experience of Regulatory affairs : 3-4 years - Knowledge & Experience of country registration & regulation for Korea, Japan, China etc - Knowledge of ultrasound medical device and international standards such as IEC60601-1, ISO14971 and etc - experience of KGMP & ISO13485 audit - Bachelor's degree in biomedical engineering and electronics - ÀüÀÚÀÇ·á±â¼öÀÔ¾÷ü °æ·Â ÇÊ
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A d d i t i o n a l R e q u i r e m e n t s |
Additions |
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