Profile

MS Nicole Landreville, RAC

GE Healthcare

Contact Details

GE Healthcare
RAPS Fellow
Bronze Member
RegEx Pro

Social Links

Bio

With a combined 19 years of RA experience, Nicole Landreville is always more than happy to share her knowledge with her RAPS peers. Ms. Landreville joined GEHC RA team in 2007 as part of the Ultrasound Team in Milwaukee, WI. All through the first 5 years of her career at GEHC, she provided Regulatory Affairs guidance to design teams in the preparation of premarket submission and management of market approvals for multiple products designed for global markets. Subsequently, Mr.Landreville joined the Global Regulatory Intelligence team where she focused on requirement flow down activities for 3 years. Currently, Ms. Landreville currently takes great pride in RA Project Management for the GEHC DGS team (Detection and Guidance Solutions) providing RA strategy planning and implementation for bone densitometers and mammography systems.

In 1997, Ms.Landreville obtained her BSc degree in electrical engineering from Ecole Polytechnique of Montreal. She began her professional career in quality assurance and regulatory affairs at ORTHOsoft Inc., a computer-assisted surgery system manufacturer in Montreal (now owned by Zimmer).
In 2000, Ms.Landreville joined World Heart Corporation in Ottawa as Quality Control Electrical Engineer working on the development of a ventricular assistant device.
In 2002, Ms.Landreville accepted a position as Director of RA / QA for an electrophysiological monitoring device manufacturer in Oakville, Ontario (Excel-Tech Ltd now owned by Natus).

My career objectives are to work with cross-functional teams of smart people to provide safe and effective products to our customers, to our world-wide communities, to our friends and family members.

Specialties: I am passionate about compliance to Worldwide medical device regulatory requirements.

Position Title

Director, Manager

Education

Ecole Polytechnique de Montreal
Montreal, Quebec, Canada
Bachelor of Electrical Engineering, 1996
Electrical Engineering - Project Management specialty
1992 To 1996

Year Entered Profession

1998

Current Organization Type

Industry

Job History

GE Healthcare
Regulatory Affairs Program Manager - Detection and Guidance Solutions (DGS) - Women's Health - Lunar
Burlington, ON
March 2015 - present

GE Healthcare
Regulatory Affairs Program Manager
Burlington, ON
March 2015 - present

GE Healthcare
Regulatory Affairs Leader
Milwaukee, WI
April 2007 - April 2011

Excel-Tech Ltd (XLTEK)
Director of Quality and Regulatory
Oakville, ON
September 2002 - April 2007

WorldHeart
Electrical Quality Engineer
Ottawa, ON
January 2000 - January 2002

Orthosoft
Quality and Regulatory Manager
Montreal, QC
January 1997 - January 2000

Regional Interests

Africa, Asia, AUSSI/NZ, Canada, Europe, Latin America, Middle East, United States, Worldwide

Product Interests

Medical Devices