Diane L Brinza is a highly qualified expert, that works in Sharp Enterprises as a President since 2010. Diane L Brinza gained professional experience in more than eight positions at various companies. Diane L Brinza went to the University of Minnesota and was studying from 1985 to 1987. Otsego, Minnesota is the area, where this professional was known to be situated. This professional's phone and email can be easily accessed through Connexy by request.
Name variants:
Diana Brinza
Contact Information
Last Update
Jul 10, 2022
Email
db**@aol.com, mb**@aol.com, db**@gmail.com
Location
Otsego, MN
Company
Sharp Enterprises
Workplace
President
Work History
Director of Regulatory Affairs
5600 Rowland Rd SUITE 200, Minnetonka, MN 55343
Feb 2010 — Aug 2015
Director of Regulatory
9600 west 76Th St SUITE T, Eden Prairie, MN 55344
Overall management and strategic direction for regualtory affairs. Management of all IDE and international regulatory correspondance.
Apr 2007 — Dec 2009
Senior Regulatory Affairs Specialist
100 Boston Scientific Way, Marlborough, MA 01752
Manage and author US, Japan and European regulatory submissions for new and existing products within Interventional Cardiology division.
Sep 2004 — Apr 2007
Regulatory Affairs Supervisor
3515 Lyman Blvd, Chaska, MN 55318
Manage and author regulatory submissions for US and International market authorizations including postmarket activities such as ASR, MDR, DMF, EUDMF and PMA Progress Reports.
2000 — Sep 2004
Manufacturing Supervisor
250 south Kraemer Blvd, Brea, CA 92821
Coordinate antibody production, concentration, quantitiation activities for invitro diagnostic products.
1991 — 2000
Manufacturing Supervisor
Coordinate viral and tissue culture production activities for invitro diagnostic products.
1991 — 1995
Education
1985 — 1987
1983 — 1985
Occupations
Executive
Chairperson
Chief Executive
Skills
Regulatory Affairs
Fda
Regulatory Submissions
Iso 13485
Medical Devices
Capa
Pma
Medical Device Directive
Design Control
21 Cfr
Quality System
Validation
Gmp
Biotechnology
R&D
V&V
Iso 14971
Ce Marking
Ide
Clinical Trials
Regulatory Requirements
Biomedical Engineering
Lifesciences