Joonseok Ryoo Email and Phone Number
Regulatory Affairs and Quality Assurance specialist with over 8 years of experience in the medical device and IVD industries. Proven track record of ensuring global regulatory compliance, obtaining critical certifications, and enhancing quality management systems across multiple markets. Skilled in aligning technical documentation with the latest regulatory standards and driving continuous improvement through risk management and audit processes. Passionate about supporting businesses in achieving excellence while ensuring patient safety and market access.
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Sr. Compliance Manager (Regulaotry, Quality)AivisSeoul, Kr -
Regulatory Affairs ManagerOsang Healthcare Co., Ltd. Jun 2022 - Present안양Leading regulatory compliance for IVDR and UKCA certifications in the glucose monitoring device sector. Successfully streamlined technical documentation processes, collaborated with cross-functional teams to enhance cybersecurity validation, and ensured product safety through risk management. Proactively addressed compliance gaps to secure timely market access. -
Regulatory Affairs Manager & PrrcM.I.Tech Co., Ltd. Apr 2019 - May 2022수원Managed the IVDR transition, ensuring alignment with regulatory requirements for glucose monitoring devices. Spearheaded quality system improvements and played a key role in securing international certifications (IVDD, ANVISA, MFDS). Supported successful QMS audits and post-market surveillance processes. -
Qa SpecialistCorentec Feb 2017 - Apr 2019서울 서초구 / 충남 천안시Led external audits and improved QMS in accordance with ISO 13485, FDA QSR, and KGMP. Played a pivotal role in enhancing supplier quality and post-market processes, driving continuous improvements in compliance and audit readiness. -
Qa Specialist(주)로고스바이오시스템스 Jan 2016 - Feb 2017대한민국 경기도 안양Handled third-party and customer quality audits, ensuring ISO 9001 compliance. Contributed to the establishment of environmental regulation compliance systems, including RoHS II technical documentation. -
Quality EngineerTe Connectivity Aug 2014 - Apr 2015대한민국 경기도 수원Facilitated mass production approval processes for Samsung’s Mobile Communication Division, with a focus on process optimization and capability monitoring. -
InternshipPosco Dec 2013 - Feb 2014대한민국 서울 강남구- Collected and arranged sales & manufacturing data for stainless products - stainless processing group
Joonseok Ryoo Education Details
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4.03/4.5 -
휘문고등학교
Frequently Asked Questions about Joonseok Ryoo
What company does Joonseok Ryoo work for?
Joonseok Ryoo works for Aivis
What is Joonseok Ryoo's role at the current company?
Joonseok Ryoo's current role is Sr. Compliance Manager (Regulaotry, Quality).
What schools did Joonseok Ryoo attend?
Joonseok Ryoo attended 동국대학교, Gachon University, 휘문고등학교.
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