Jina Ha

RA Specialist @ Nano Ditech Corp

About

Have various carrier as medical device RA& QA around 10 yrs. Also interested in the teaching and sharing my knowledge and experience who wants to hear and learn from me. And I love to build& cultivate the organization culture as bright side.

Country

United States

City

Cranbury

Industry

Medical Device

Skill

Regulatory Affairs, FDA, 의료기기, GMP, 품질시스템, 관리, QA, Regulatory Affair, CE, IVD, IVDR

Experience

RA Specialist

Nano Ditech Corp

2021-12 - Present · 4 yrs 10 mos

NJ, United States

Senior RA/QA Specialist

Lumenis

2018-1 - 2021-12 · 4 yrs

QA/ RA Manager

BNR Co.,Ltd.

2013-2 - 2017-12 · 4 yrs 11 mos

Seoul, Rep of Korea

May, 2013- KGMP(Korean Good Manufacturing Practice) regular recertification audit response. August, 2013- CE(ISO 13485 Surveillance and MDD recertification) June, 2014- KGMP(Korean Good Manufacturing Practice) relocation audit response. August, 2014- CE(ISO 13485 and MDD Surveillance ) Audit response. (Audited by ITC notified body). October, 2014 CE(ISO 13485 for sterile trocars) Audit response. (Audited by DNV GL notified body) November,2014 attended at MEDICA Fair as assistant(Duesseldorf) May, 2015- CE(ISO 13485 and MDD: initial audit ) Audit response. (Audited by DNV GL notified body). August,2015 Dedicated to performing of Acquisition International Standards Certification Support Program(Performed with KTL) November,2015 attended at MEDICA.Fair as leading manager (Germany, Duesseldorf) May 2016 KGMP(Korean Good Manufacturing Practice) regular recertification audit response.-BNR Co.,Ltd. May, 2016 KGMP(Korean Good Manufacturing Practice) first certification audit response.-Mecadian 18th-20th May, 2016 attended at Exposanita Fair as leading manager(Bologna, Italy) June, 2016 CE(ISO 13485 and MDD: Regular audit ) Audit response. (Audited by DNV GL notified body August, 2016 attended at MEDICA Fair Asia(Singapore) as a leading manager October,2016 attended at Indonesian International Hospital Medical Pharmaceutical Clinical Laboratories Equipment Exhibition – Hospital Expo 2016 as a leading manager November,2016 attended at MEDICA Fair(Dusseldorf, Germany) as a leading manager December, 2016- Performed internal audit(BNR Co., LTD) . March, 2017 Completion of additional product item audit(KGMP) 23th of March 2017 Audit response additional product item audit(By TUV Rheinland stage 1 audit) 10th -12th of May 2017 Audit response additional product item audit(By TUV Rheinland CE MDD and ISO 13485) 12th-14th of June 2017 ) Recertification audit(ISO 13485) and regular audit(CE MDD) response (Audited by DNV GL notified body)