Jessica Diaz
Quality Assurance/ Regulatory | Medical Device Complaint Handling & Reporting| QMS ISO 9001 and ISO 13485| QSR 21 CFR Part 803 and Part 820
- Role
- Mdr Complaint Specialist, Consultant at BD
- Location
- Totowa, NJ, US
- LinkedIn followers
- 500 followers
About Jessica Diaz
I am a seasoned Compliance and Regulatory Specialist with three years of experience reporting Adverse Events related to Medical Devices- including deaths, serious injuries and malfunctions to help identify and address potential safety issues. Efficient at fostering collaboration across a multi- functional team. Possess a solid understanding of Quality System Regulation 21 CFR Part 820 and Part 803 (US FDA), EU MDR and QMS standards ISO 13485, ISO 9001
Experience
Mdr Complaint Specialist, Consultant
Jun 2025 — Present
Review, approve and write Executive summaries for 100+ Investigations monthly ensuringcompliance with FDA• Prepare and submit Supplemental Medical Device Reports (eMDRs) to the FDA throughTrackwise, ensuring accuracy, compliance, and adherence to submission timelines• Collaborate with cross-functional teams including Quality Engineering to suggest correctiveactions to improve investigation quality
Education
Berkeley College
Associate, Applied Science
Berkeley College
Bachelor, Business Administration, Health Services Management
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