Mary E Donlin

Consultant

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Location:

4333 Reiland Ln, Shoreview, MN 55126

Industry:

Medical Devices

Work:

Mrc/X, Llc
Consultant
Admedus Mar 2014 - Jul 2019
Vice President Regulatory Affairs and Compliance
Medtronic Jun 2013 - Feb 2014
Principal Regulatory Affairs Specialist
Medtronic Apr 2009 - Jun 2013
Senior Regulatory Affairs Specialist
Medical Graphics Corporation Feb 2005 - May 2008
Senior Product Development Manager

Education:

University of St. Thomas 2007 - 2007
Masters, Master of Arts, Management Miller High School
University of Minnesota - Twin Cities
University of Minnesota
Bachelors, Bachelor of Science

Skills:

Medical Devices
Fda
Iso 13485
Regulatory Affairs
Capa
Quality System
Design Control
Pma
Regulatory Submissions
R&D
Ce Marking
Validation
Cross Functional Team Leadership
Product Development
Iso 14971
Quality Auditing
Regulatory Requirements
Medical Device Directive
V&V
Sterilization
Gmp
Commercialization
21 Cfr
Clinical Trials
Product Launch
Premarket Approval
Corrective and Preventive Action
U.s. Food and Drug Administration
Management
Process Improvement

Languages:

English

Certifications:

Iso 13485 Lead Auditor
License 02020911
Rabqsa, License 02020911

Mary Donlin

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Mary Ann Donlin