Elizabeth Reger
Denver,CO
Summary
Diligent medical device engineering and regulatory affairs professional with five years experience in life science product commercialization. Successful record in team leadership, sales and financial development, project management, and regulatory strategy, submissions, and FDA approvals.
Overview
5
5
years of professional experience
Work History
Regulatory Affairs Manager
REGULATORY AFFAIRS
04.2021
- Co-authored sections for 510(k) applications and authored Pre-Submissions, 513(g) Requests, Additional Information Responses, and multiple Breakthrough Device Designation requests, four of which have received BDD designation by FDA
- Wrote Route to Market Assessments, 510(k) gap analyses, and performed post-market research projects for various medical devices
- Performed risk management of various potential regulatory strategy options
- Registration and listing for 10+ medical device manufacturers and initial importer facilities
- Provided written procedures on steps for registration and listing
- Led business development/ sales calls, prepared appropriate contracts
- Currently managing 39 project codes with opportunity budgets exceeding 1.3MM for 2023.
Team Lead
10.2018
- Assumed leadership role for a seven-person engineering team to effectively implement and uphold a Quality Management System for 12 clients in the medical device, pharmaceutical, and biotechnology industry
- Responsible for identifying problems, such as non-conformities, and corrections using non-conformance investigations procedure.
QUALITY COMPLIANCE – Quality Engineer
EVERSANA Life Sciences Services
07.2018 - Current
- Development of Standard Operating Procedures (SOPs) and Work Instructions (WIs) to adhere to quality compliance requirements of cGMP 21 CFR 820 including QMS, design controls, design reviews, and process validation
- Responsible for Software Validation and Verification.
Education
Bachelor of Science - Chemical and Biological Engineering
University of Colorado
Master of Science - Applied Biomedical Engineering
Johns Hopkins University
Skills
- SKILLS & ABILITIES
- Regulatory/Compliance: 21 CFR 820, ISO 9001, ISO 13485, GMP, GDP, GLP, Regulatory Compliance and Documentation, Risk Management, FDA Regulations, Technical Writing, Clinical Trial Protocols, Regulatory Strategy Development
- Software:
- MATLAB, Minitab, Aspen HYSYS, Extedo, Lorenz
- Laboratory: Cell Culture, Pipetting, PCR, ELISA, Size Exclusion, Gas, and High-Performance Chromatography (SEC, GC, HPLC)
Timeline
Regulatory Affairs Manager
REGULATORY AFFAIRS
04.2021
Team Lead
10.2018
QUALITY COMPLIANCE – Quality Engineer
EVERSANA Life Sciences Services
07.2018 - Current
Bachelor of Science - Chemical and Biological Engineering
University of Colorado
Master of Science - Applied Biomedical Engineering
Johns Hopkins University
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