조예진 Email & Phone Number

대한민국 서울

I am currently working as a member of the RA team at L&K BIOMED, a manufacturer of spinal implants medical devices.- Successfully obtained new registrations for 6 Implant (Class C) and 7 Instrument products in Malaysia.- Secured new registrations for 2 Implant (Class C) and 1 Instrument product in Thailand, while also handling the renewal of 5 Implant (Class C) and the change notification process for 3 Implant (Class C) products.- Successfully completed the renewal process for 10 Implant (Class C) products in Vietnam, and currently in progress with the registration of 2 Implant (Class C) and 1 Instrument product.Currently in progress with new registrations for Implant (Class C) products in various countries including Singapore, the Philippines, Brazil, and Australia.- Currently in progress with new registrations for Implant (Class C) products in various countries including Singapore, the Philippines, Brazil, CE (MDR) and Australia.- In the process of renewing the CDSCO license in India.- Support for CE certification audits and ISO quality system audits

대한민국 서울

I worked as a RA(QA) team member at SML Genetree, an in vitro diagnostic medical device manufacturer.- IVDR progress (communication with a European representative) 1) Register Legacy devices (Class III) 2) EUDAMED actor registration 3) IVDR gap analysis- Response to ISO 13485 inspection- QMS document revision (IVDR application)- QMS internal training- RA permit work support

대한민국 서울

I worked as a member of the RA&QA team at a biopharmaceutical (cell therapy product) manufacturing company.- ISO 9001 inspection and GMP regular inspection support.- Revision of quality management system(QMS) document (SOP, Quality manual, etc.)- Management and storage of QMS documents (in charge of the document storage room)