Regulatory Affairs Project Manager @ (May 2023 - May 2026)
Regulatory Affairs Postmarket Surveillance Specialist III (promotion) @ (March 2021 - May 2023)
Regulatory Affairs Postmarket Surveillance Specialist II @ (January 2019 - March 2021)
Raw Materials Chemist I @ (August 2018 - January 2019)
Research Associate Regulated Products @ (May 2017 - August 2018)
Undergraduate Student Researcher @ (August 2016 - May 2017)
R and D Technician I @ (June 2016 - April 2017)
Student Research Assistant @ (August 2014 - June 2016)
Undergraduate Summer Research Student @ (June 2014 - August 2014)
Marissa Brooks Education
University of Utah
Bachelor of Science (BS) (Chemistry with an emphasis in Biology)
2014-2017
MiraCosta College
Associate of Arts (A.A.) (Mathematics and Science)
2008-2014
Marissa Brooks Skills
21 CFR
Analytical Chemistry
Blood glucose monitoring systems
CFR
Change Control
Communication
Complaint Investigations
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
Data Analysis
Decision-Making
Design Control
External Audits
Failure Analysis
Gas Chromatography
Good Manufacturing Practice (GMP)
High Level Of Accuracy
High-Performance Liquid Chromatography (HPLC)
IEC 62304
IEC 82304
ISO 13485
ISO 14971
ISO Standards
In Vitro Diagnostics (IVD)
Internal Audits
Interpersonal Skills
Knowledge of 510(k) Submissions
Leadership
Liquid Chromatography-Mass Spectrometry (LC-MS)
MDR
Medical Device Regulation (MDR)
Medical Devices
Microsoft Office
Organic Chemistry
Problem Solving
Process Improvement
Project Management
Protocol Development
Public Speaking
Quality Assurance
Quality Auditing
Quality Control
Quality System
Regulatory Affairs
Regulatory Compliance
Regulatory Reporting
Regulatory Requirements
Regulatory Strategy Development
Regulatory Submissions
Research and Development (R&D)
Risk Management
Root Cause Analysis
Scalability
Software
Statistical Process Control (SPC)
Statistics
Technical Files
U.S. Food and Drug Administration (FDA)
Verification and Validation (V&V)
Written Communication
analytical thinking
Marissa Brooks Summary
Marissa Brooks, based in San Diego, CA, US, is currently a Regulatory Affairs Manager at iRhythm Technologies, Inc.. Marissa Brooks brings experience from previous roles at ARKRAY,Inc., bioMérieux and Teva Pharmaceuticals. Marissa Brooks holds a 2014 - 2017 Bachelor of Science (BS) in Chemistry with an emphasis in Biology @ University of Utah. With a robust skill set that includes 21 CFR, Analytical Chemistry, Blood glucose monitoring systems, CFR, Change Control and more. Marissa Brooks has 1 emails and 1 mobile phone numbers on RocketReach.
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