Glen Ronald Mangseth is a eficient professional, working in Thermo Fisher Scientific main office of which is in 625. on the position of Senior Manager, Regulatory Affairs from 2019. This person has earned professional experience in more than eight positions at various companies. Glen Ronald Mangseth went to the University of California, Berkeley, Haas School of Business and got education. Los Altos, California is the area, where this professional was lastly known to settle. This professional's e-mail and phone can be easily accessed through SoftwareOfficial on demand.
Name variants:
Glenn Mangseth,
Glenda Mangseth,
Glenys Mangseth
Last updated Apr 15, 2024
Contact Information
Last Update
Jul 4, 2022
Email
kt**@sbcglobal.net
Location
Los Altos, CA
Company
Thermo Fisher Scientific
Workplace
Senior Manager, Regulatory Affairs
Work History
Senior Manager, Regulatory Affairs
168 3Rd Ave, Waltham, MA 02451
from Jan 2019
Regulatory Affairs Manager
Regulatory affairs manager overseeing product development and quality system activities alignment with FDA QSR and EU MDD requirements. Responsible for creation of ISO13485 compliant quality...
Jul 2015 — Nov 2018
Quality Engineer Consultant and Contractor
1235 Radio Rd SUITE 110, Redwood City, CA 94065
Responsible for a variety of quality systems/engineering activities:
Verification protocol development, testing and reports:
IEC 60601-1-2
Label integrity/durability
Component and devic...
Jun 2014 — Jun 2015
Vice President Product Development
580 Cody Rd, Mountain View, CA
Responsible for transitioning to a medical products company:
Implementation of design control processes including:
Product Development Plan
Software Development Plan
Market Document
Pr...
Sep 2013 — Apr 2014
Quality Systems Manager
3875 Hopyard Rd SUITE 300, Pleasanton, CA 94588
Quality Systems Manager responsible for FDA QSR and ISO13485 compliance
Research, writing and submission of FDA pre-market notification documents (510k)
Technical file research, writing a...
Apr 2011 — Sep 2013
Director of Product Management
48368 Milmont Dr, Fremont, CA 94538
Product Management
Market research (MRD)
Product definition (PRD)
Product performance specifications
Human factors specifications using normative data, video analysis, field research
S...
2007 — May 2011
Assoc Development Engineer, Exercise Biology Program
1 Shields Ave, Davis, CA 95616
Analog electronics design
Digital electronics design
Design of data acquisition systems for biologic/biomechanical recording
Design and fabrication of instrumentation for student Exercis...
1998 — 2007
Director - Marketing and Product Management
Davis, CA
Medical device company specializing in DC servo-motor based robotic rehabilitation devices. Served as product manager responsible for both upstream and downstream marketing activities. Activ...
Jul 1987 — Jun 1996
Education
Occupations
Executive
Senior Manager
Manager
Team Member
Operations Manager
Skills
Iso 13485
Medical Devices
Quality System
Design Control
Product Launch
R&D
Fda
Ce Marking
Product Management
Capital Equipment
Cross Functional Team Leadership
Product Development
Validation
Design of Experiments
Product Lifecycle Management
Capa
Biomedical Engineering
Market Development
Orthopedics
U.s. Food and Drug Administration
Corrective and Preventive Action
Commercialization
Gmp
Iso
Medical Device Directive
Iso 14971
Process Simulation
Fmea
Orthopedic
21 Cfr