주요 업무

Position Overview: KBIO Solutions is seeking to hire a full time or a part time to proactively collaborate with K-Bio client, medical device companies in Korea and manage US FDA/EU CE regulatory submissions of medical devices. Responsibilities will include: • Learn US FDA, Europe CE medical device registration Requirements, Clinical trial monitoring, Clinical trial statistical analyses • Lead/manage medical device registration projects to prepare regulatory submission files to gain US FDA 510(k) clearance, EU CE Marks on behalf of client companies • Inform K-Bio client companies of registration requirements including non-clinical, safety and performance testing reports and registration data in order to compile and complete regulatory submissions. • Proactively collaborate with client RA representatives and take project initiatives to communicate and overcome any challenges, and obstacles to complete registration due diligence to gain medical device approvals with US FDA and EU. • Grow and become the regulatory leader empowered with knowledge and confidence to help achieve client companies’ regulatory goals

자격 요건

Qualifications and Experience: • Graduate degree holders, college graduates, or current graduate students • Excellent written and verbal communications skills in both Korean and English • Academic background from a top-tier institution, High motivation, good attitude, and attention to detail

우대 사항

• Excellent written and verbal communications skills in both Korean and English •Life Sciences, Biomedical engineering, Nursing, Statistics B.A. Degree Holder

기타

KBIO Solutions will support required visa processing. Currently, two foreigners are working at KBIO Solutions.

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