We found the following information about Michael A Kolber at Siesta Medical, Inc., where the professional has worked as a Vice President, Clinical Affairs and Regulatory Affairs since 2015. Michael's total work experience is over 31 years, during which time this person had at least seven jobs at different places to develop professional skills. Michael studied at the University of California. Michael currently is located in East Brunswick, New Jersey. You can contact with Michael by looking for phone number or email or find exhaustive information by requesting access to the professional's additional details from SoftwareOfficial.
Name variants:
Mikael Kolber,
Mychael Kolber,
Mike Kolber,
Mikey Kolber,
Mick Kolber,
Mickey Kolber,
Micky Kolber,
Michl Kolber,
Mischa Kolber
Last updated Jun 06, 2024
Contact Information
Last Update
Jul 3, 2022
Email
al**@nj.rr.com, mi**@yahoo.com
Location
East Brunswick, NJ
Company
Workplace
Vice President, Clinical Affairs and Regulatory Affairs
Industry
Medical Devices
Colleagues
Work History
Vice President, Clinical Affairs and Regulatory Affairs
Develop and implement clinical and regulatory strategies to obtain US and EU approvals for medical devices to treat obstructive sleep apnea.
Obtained US 510(k) clearance for company's init...
from Oct 2015
Vice President, Clinical and Regulatory Affairs
125 Shoreway Rd SUITE B, San Carlos, CA 94070
Developed clinical and regulatory strategies for biotherapeutic program to provide regenerative medicine solution for cardiovascular diseases. Worked with FDA's CDRH and CBER reviewing divis...
Aug 2013 — Oct 2015
Consultant
Consulting Vice-President providing expert strategic regulatory, clinical, and quality advice, and practical hands-on implementation to small venture-backed, angel, or self-financed start-up...
Aug 2013 — Oct 2015
Co-President, Vice President, Regulatory Affairs and Quality Assurance
Sunnyvale, CA
Guided the company through the regulatory, clinical, and quality strategies for novel medical device treatments for patients with heart failure.
Collaborated with FDA reviewers (lead, reli...
Apr 2003 — Apr 2012
Vice President, Clinical Affairs, Regulatory Affairs and Quality Assurance
Created and implemented a well-integrated clinical, regulatory and quality system strategy to support market approval for a novel catheter-based stroke prevention device and procedure (PLAAT...
Feb 2000 — Mar 2003
Vice President, Regulatory Affairs and Quality Assurance
1901 Barksdale Rd, Newark, DE 19711
Effectively developed and executed regulatory strategies, including preparation and approval of 3 stent-graft technologies: the treatment of aortic aneurysms, thoracic aortic aneurysms, and ...
Feb 1995 — Feb 2000
Manager, Clinical Affairs and Regulatory Affairs
100 Boston Scientific Way, Marlborough, MA 01752
Increasing responsibilities for developing and implementing clinical and regulatory strategies for coronary and peripheral balloon catheters, guidewires, guiding catheters, and accessories....
1985 — 1995
Education
Occupations
Counselor
Executive
Vice President
Advisor
Chief Executive
Skills
Medical Devices
Fda
Regulatory Affairs
Quality System
Clinical Trials
Iso 13485
Clinical Research
Quality Assurance
Capa
Biotechnology
Gmp
Start Ups
Validation
Pma
Ce Marking
Commercialization
Medical Device Directive
Product Development
Clinical Affairs
R&D
Pre Ide's
Quality System Regulation
Fda Meetings
Regulatory Strategy Development
Premarket Notifications
Special 510 'S
Pre Investigational Device Exemption Submissions
Investigational Device Exemptions
Investigational Plans
Clinical Evaluation Reports
Dossiers
Technical Files
Post Market Surveillance
FAQs about Michael A Kolber
What is the main profession of Michael A Kolber?
This professional's job is Consultant
What jobs is Michael A Kolber a professional at?
Michael A Kolber is a professional such jobs as Counselor.
Where does Michael A Kolber live?
Michael currently lives in East Brunswick, New Jersey.
What is Michael's email?
Michael A Kolber's email is al**@nj.rr.com and mi**@yahoo.com.
How many companies did Michael A Kolber work at?
Michael A Kolber worked at seven jobs.
Where has Michael A Kolber studied?
Michael studied at the University of California.
What languages does Michael A Kolber speak?
Michael A Kolber speaks English.
Are there any industries, that Michael A Kolber works in?
This person works in Medical Devices industry.