For over 12 years Bill Welch has been working in different jobs. Recently, this professional worked as a Sr Manager RA/QA in Surgicount Medical enhancing knowledge. This person graduated from California State University-Fullerton in 1980 where this professional received all the skills. You can find this person in Santa Ana, California, where he is located nowadays. SoftwareOfficial has all the information you need to contact Bill Welch, such as this person's phone number or e-mail. Send the request to get more info.
Name variants:
Billy Welch,
Billie Welch
Last updated Jul 04, 2024
Contact Information
Last Update
Feb 1, 2016
Email
ww**@yahoo.com
Location
Santa Ana, CA
Company
Workplace
Sr Manager RA/QA
Irvine, CA
Industry
Medical Devices, Mfg Surgical/Medical Instruments
Colleagues
Work History
Sr Manager RA/QA
Irvine CA
• Planned and implemented Quality System elements consistent with scope of company operations and in compliance with 21 CFR part 820 and ISO 13485
• Devised plan for obtaining EC and QS cert...
Feb 2011 — May 2013
Sr Manager RA
Wrote and gained approvals for IDE and PMA supplements for a variety of design, process and clinical trial modifications.
Wrote and gained approvals for various EC Change notifications neces...
May 2009 — Jan 2011
Associate Director of Regulatory Affairs
Responsible for Drug eluting stent design project team inputs and compilation of original IDE necessary to launch US clinical trials. Amended MAFs on behalf of licensees and provided inputs ...
Jul 2006 — Aug 2008
RA Contractor
Developed and submitted IDE and 510k contents for devices used to acutely treat post-AMI patients
Sep 2004 — Jul 2006
RA Project Manager
Developed and submitted contents of IDEs, PMAs, and 510ks for devices used in treating cardiac arrhythmias.
Sep 2000 — Feb 2004
Education
1975 — 1980
1974 — 1975
Occupations
Executive
Senior Manager
Operations Manager
Skills
Clinical Trials
510 K
Medical Devices
FDA
Regulatory Affairs
Compliance
CE marking
Quality System
Fda
Regulatory Submissions
Quality Assurance
Ce Marking
Iso 13485
Capa
Quality Auditing
Design Control
R&D
V&V
Glp
Technology Transfer
Commercialization
21 Cfr Part 11
Regulatory Requirements
Biotechnology
Biomedical Engineering
Iso 14971
Validation
Gmp
Change Control
Medical Device Directive
Sop
Complaint Management
Gcp
FAQs about Bill Welch
What's the main profession of Bill Welch?
The expert is a Sr Manager RA/QA.
What jobs is Bill Welch proficient at at?
Bill Welch is a professional Executive and Senior Manager jobs.
Where does Bill Welch currently live?
The expert lives in Santa Ana, California.
What is Bill's email?
The professional's email is ww**@yahoo.com.
How many companies did Bill Welch work at?
Bill Welch worked at five jobs.
What education does Bill Welch have?
Bill studied at the California State University-Fullerton from 1975 to 1980.
What is the industry that Bill Welch worked in?
Bill Welch works in Medical Devices industry.
Are there any skills, that Bill Welch has?
Bill has the following skills:.