Lauren Baker
Regulatory Affairs Associate | Becton Dickinson | Biomedical Engineering | Medical Device Design & Development | EU MDR & Regulatory Compliance | Genetic Engineering and Cell Culture
- Role
- Regulatory Affairs Associate Medical Device Regulations Eu Mdr Technical Documentation at BD
- Location
- Phoenix, AZ, US
- LinkedIn followers
- 500 followers
About Lauren Baker
As a Biomedical Engineer, I value opportunities in advancing healthcare through…
Experience
Regulatory Affairs Associate Medical Device Regulations Eu Mdr Technical Documentation
Jan 2025 — Present
Supports vascular surgical products across the EMEA region by ensuring regulatory compliance, facilitating and sustaining product registrations, and collaborating with cross-functional teams to maintain market access and patient safety - Drives EU Medical Device Regulations (MDR) product submissions by authoring, compiling, and maintaining technical files, regulatory dossiers, and product registrations to ensure compliance with European regulatory standards- Led regulatory efforts in an MDR remediation project for ePTFE Vascular Grafts within first year as a regulatory affairs associate by authoring and submitting the technical documentation to BSI, successfully navigating a dedicated interactive review process, and securing a CE certification in under two months post-submission- Ensures adequate documentation and reporting of BD Peripheral Intervention\'s compliance to EU standards and notified body requirements across the EMEA region - Provides regulatory team support and contributes to special projects, ensuring timely execution and compliance with organizational and regulatory requirements
Education
Ira A. Fulton Schools of Engineering at Arizona State University
Bachelor of Science in Engineering - BSE
2018 — 2022
Lincoln-Way East High School
High School Diploma
2014 — 2018
Ira A. Fulton Schools of Engineering at Arizona State University
Master of Science - MS
2022 — 2023
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