Manage registration of digital medical devices in APAC, EMEA, and LATAM. Handle change management of digital device. Continue auditing Straumann subsidiaries and suppliers as lead auditor according to ISO 13485.Support RA/QA remediation for new partner.

Registration and license renewal of dental devices mainly for APAC countries; AUS/NZ, China, Japan, Korea, Taiwan, Malaysia, Singapore, India.etc. plus experienced for Israel and Ukraine. GMDN Administrator at Straumann. Quality audit at the distributor / subsidaries.

Registration dental implants, prosthetics and regenerative devices in Korea, Also local quality management.

Registration of cardiac products in Korea: Pacemaker, ICD, Catheter, Stent, Heart valve. Establish local quality managment, manage local testing, also take a responsibility of reimbursement.