Open to opportunities

Nahee Kim

@naheekim

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Biology graduate with 3.5 years' R&D and regulatory experience in in-vitro medical devices.

South Korea

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What I'm looking for

I seek R&D or regulatory roles in medical device companies where I can apply verification/validation, quality documentation, and cross-functional collaboration to drive compliant product development.

I am a biology graduate with 3.5 years of hands-on experience at an in-vitro medical device company, focused on R&D, technical support, and cross-functional collaboration.

I have performed verification and validation testing, authored protocols and reports, and maintained technical and quality documentation including Design History Files and Risk Management Files.

I developed and updated R&D procedures in line with internal SOPs and global regulatory requirements, supported post-market activities, customer claims investigations, and change control with the quality team.

I am fluent in English and a native Korean speaker, known as a reliable team player with accurate record keeping, strong teamwork, and a quick ability to learn.

Experience

Work history, roles, and key accomplishments

Researcher

Abbott Diagnostics Korea, Inc

Mar 2021 - Jul 2024 (3 years 4 months)

Performed verification testing and design control activities, authored protocols and reports, and maintained Design History and Risk Management files to support R&D and regulatory compliance. Managed post-market activities and collaborated with quality on customer claims and change control.

Verification Design Control Risk Management Technical Documentation SOP Development Regulatory Compliance

Student Researcher

Kyong-gi University

Sep 2020 - Feb 2021 (5 months)

Conducted diagnostic and quantitative experiments within molecular genetics projects and contributed to laboratory research procedures. Supported experimental design and data collection for university research studies.

Molecular Biology Diagnostics Experimental Design Data Analysis Protocol Development Research & Documentation

Education

Degrees, certifications, and relevant coursework

Kyong-gi University

Bachelor's degree, Biology

Activities and societies: Student Researcher in the Molecular Genetics Laboratory; participated in diagnostic and quantitative experiments and laboratory research projects.

Completed a Bachelor's degree in Biology, graduating in February 2021 with coursework and research experience in molecular genetics and diagnostics.