Mike Park

***** ******** **. ************, **. **258

Tel; 904-***-**** e-mail; emgxrk@r.postjobfree.com

Qualifications

KFDA Medical Device Approval (Class I, II, IIIa)

Japanese Government Medical Device Safety

Approval (Class IIIa)

Chinese Government Medical Device Register (Class II)

US FDA Medical Device 510k Register (Class I, II, IIIa)

ISO 9000/En46000

Professional Experience.

2002-2011 Union Medical Laser Inc.-(Company Closed)

Responsible for FDA Regulatory Affairs-maintaining 510k status and Annual Reports to FDA, labeling compliances, marketing material compliances, sales lists, responding questions or instructions from FDA Authorities, etc.

Most of Latin America requires FDA 510k or European CE Mark except Brazil.

Marketing & sales in US and South America.

1993-20001 Union Medical, Inc

Responsible for international sales & marketing to Asia, Europe, and US

Responsible for Regulatory affairs.

FDA 510k registering (Class I, II, IIIa) ; Surgical Lamp, Electro Surgical Units, Electro Surgical Coagulators, CO2 Surgical Lasers, Fatal Monitors etc.

Korean FDA Registering. (Class I, II, IIIa) Domestic & Imported Products.

Electro Surgical Units, Electro Surgical Coagulators, CO2 Surgical Lasers, Fatal Monitors, Cataract Surgery Units, Erbium Dermatology Laser, Tattoo removal lasers, Skin resurfacing Scanner, ECG Monitors

Chinese Government Registering.- Electro Surgical Units and Electro Coagulators.-working with local

Japanese Government Safety Approval for CO2 surgical Laser (Class IIIa)

ISO9000/En46000

1988-1993 Kolon International Corp. (South Korea)

Responsible for sales &marketing medical devices to Russia and South America.

Education

Bachelor degree. Hankuk University of Foreign Studies. (South Korea)

Major; English Literature & Language /Minor; Business Administration