Manager of Regulatory Affairs @ (July 2021 - January 2023)
Regulatory Affairs Manager @ (October 2019 - July 2021)
Senior Regulatory Affairs Specialist @ (February 2018 - October 2019)
Regulatory Product Specialist @ (January 2017 - February 2018)
Regulatory Operations Specialist @ (January 2015 - December 2016)
Quality Assurance Technical Specialist @ Carbon Medical Technologies (January 2014 - December 2014)
Quality Assurance Associate @ Carbon Medical Technologies (January 2013 - December 2013)
Behavioral Specialist @ Stepping Stones for Living (October 2011 - December 2012)
Housing Maintenance @ (May 2010 - May 2011)
Forestry Department Rochester Park and Recreation @ (June 2007 - September 2010)
Jake Schultz Education
University of Minnesota-Duluth
Bachelor of Science (B.S Biology, Business Administration)
2007-2011
Jake Schultz Skills
Adobe Acrobat
Presentations
Oral Communication
Regulatory Approvals
Attention to Detail
Leadership
Regulatory Submissions
FDA
Critical Thinking
Unique Device Identification (UDI)
510(k)
Teamwork
Microsoft Office
Quality Assurance
Time Management
ISO 13485
Quality System
Medical Devices
Cross-functional Team Leadership
Communication
Regulatory Intelligence
Regulatory Projects
CE marking
Regulatory Affairs
Corrective and Preventive Action (CAPA)
Code of Federal Regulations
Regulatory Requirements
Technical Files
Medical Device Directive
MDR
Design Control
Regulatory Documentation
Regulatory Reporting
Regulatory Compliance
Regulatory Audits
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
Good Manufacturing Practice (GMP)
21 CFR
Regulatory Strategy Development
Cpr Certified
Microsoft Word
Documentation
PowerPoint
Unique Device Identification
Microsoft Excel
Conflict Resolution
Continuous Improvement
Process Improvement
Customer Service
Unique Device Identification Udi
510k
Corrective And Preventive Action Capa
Cross Functional Team Leadership
Good Manufacturing Practice Gmp
U.S. Food And Drug Administration Fda
Standard Operating Procedure Sop
u.s. Food and Drug Administration
Corrective and Preventive Action
Standard Operating Procedure
Good Manufacturing Practice
Jake Schultz Summary
Jake Schultz, based in Saint Paul, MN, US, is currently a Global Manager, Regulatory Affairs Operations - Regulatory Intelligence at Olympus Corporation of the Americas. Jake Schultz brings experience from previous roles at Welly Health PBC, Key Surgical and Teleflex Incorporated. Jake Schultz holds a 2007 - 2011 Bachelor of Science in B.S Biology, Business Administration @ University of Minnesota-Duluth. With a robust skill set that includes Adobe Acrobat, Presentations, Oral Communication, Regulatory Approvals, Attention to Detail and more. Jake Schultz has 1 emails and 2 mobile phone numbers on RocketReach.
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