** ********, ****

Dear HR Manager,

I am applying for the above position. Below is a brief description of my work experience, educational background and achievement.

I had been an independent QA and Regulatory consultant since 2005. My client list includes GE, MRI division (RA consultant), Incumedx, Neurovascular product (RA/QA consultant), Gilead Sciences (QA/RA Senior Consultant, CMC, Internal and External audits ), St Jude Medical (Neuromodulation and Atrial Fibrillation), Philips Healthcare (BIPAP, CIPAP, Respirator, Defibrillators, CAPA, Complaints and remediation of warning letter), Johnson and Johnson as External Lead Auditor, Aubrey Inc.(Tissue Engineering, Medical Device Company, 510K, CE Marking, Japan, Australia and Canada regulatory submissions, ISO 13485 and 21 CFR 820 Quality System Implementation), MicroPhage,Inc (IVD Medical Device, 510K, CE and Canada submission, QSR, ISO 13485 implementation, Supplier Audit, Stability program, Design Control, Notified Body) Genzyme Transgenic Corporation (Pre-IND preparation, Anti- CD 137, Anticancer Mab for Solid Tumor and Hematological Cancer), Genentech, Inc.,(Biologics, Stability Program (ISO 9001 Certification, Internal Audit). MDS Pharma Services(Quality System 21 CFR 210/211, Clinical Data audit, DPMK), Biotechtronix Inc.(Method development, Medical Device and Validation) and Biozone Laboratory Inc., (Quality System, Stability Program Review, cGMP compliance, QC, QA). Gilead Sciences, NDA, BLA, QA auditing, CMO audit and quality data review.

I am confident that I can a great asset to any firm because of the following factors:

a) Had more than 30 years of quality and regulatory experience in biotech, pharmaceutical and medical device industry, QC, QA, CMC, stability program, quality system implementation for 21 CFR 820, 210, 211, ISO 13485, MDD Medical Device, IVDD.

b) Expert knowledge in CMC.

c) Expert in building and training a quality team and set policy.

d) Wrote, edited and reviewed thousands of documents on medical device, biologics and pharmaceutical. Documents include BLA, 510K, PMA, NDA etc.

e) Successful transferred 3 medical device products to a foreign CMO.

f) Translated regulatory and quality documents to several Chinese CMO and vice versa.

g) Managed CMO/CRO with qualification, audit, method and process transfer.

h) Performed hundreds of internal and external quality audits for onsite clients and CMO/CRO.

i) Have years of experience in method development and validation and computer validation. IQ/OP/PQ. Master Validation List, HPLC, LC/MS/MS.

j) Obtained 10 US patents on protein chemistry and a national award.

k) Have successfully implemented ISO 13485 and 21 CFR 820 for 4 medical device companies.

l) Conversant with human factor analysis and requirement of medical devices.

m) Active member of the Regulatory Affairs Professional Society and American Society for Quality and always kept abreast of new developments in regulation and quality.

n) Successfully helped clients to apply about 10 CE marking and 510K.

o) Completed a M.Sc degree in Regulatory Affairs from Johns Hopkins.

p) I had helped clients to remediate FDA 483 and warning letters.

q) Had performed many quality audits both internal and external.

r) Had interacted with FDA officers many times.

s) I can speak and write three languages English, Chinese (Speak, read and write), Cantonese and Malay (speak, read and write) and have excellent communication and people skills.

t) I am a team player and always meet deadline.

u) Love to work in a startup environment.

Please do not hesitate to contact me. My cell is 415-***-**** and email is adt3qc@r.postjobfree.com

KC Low

Resume Attached

US Citizen.

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