Regulatory Affairs Specialist - Bio-Rad Laboratories - Hercules, CA
(2026-03)
Technical Documentation, CE marking, GSPR Compliance, Change management activities, Global Product Registration, IVDR Compliance, GMED Audit Preparation
- Assisted in compiling and maintaining IVDR Class C technical documentation per EU IVDR (Regulation (EU) 2017/746), including Annex II/III content such as device description, intended use, classification rationale, labeling/IFU, and GSPR compliance evidence.
- Maintained EU IVDR technical files throughout the product lifecycle by processing change requests, updating documentation, and supporting impact assessments to sustain compliance.
- Assembled and submitted low- to medium-complexity regulatory dossiers supporting global product registrations and market access.
- Coordinated with technical writers, desktop publishers, and regulatory specialists to produce accurate, submission-ready documentation.
- Collaborated with R&D, QA, Marketing, Manufacturing, and Planning teams on documentation needs supporting regulatory strategy, registration milestones.
- Contributed to product classification activities, including EMDN/GMDN coding support, as part of technical file maintenance.
- Applied analytical and critical-thinking skills to interpret regulatory requirements, resolve documentation issues, and support compliance across submissions.
Research Associate II - Alexza Pharmaceutical - Fremont, CA
(2023-06 - 2025-10)
Technical File Management, Clinical & IRB Compliance, Change management activities, Quality Management Systems (QMS), IVDR Compliance, Audit Preparation
- Prepared and maintained regulatory documentation, including Design History Files (DHF), for drug-device combination products in compliance with 21 CFR 820.30 and ISO 13485:2016.
- Performed gap analyses and implemented corrective actions to ensure product development changes met 21 CFR Part 820, ISO 13485, and ISO 14971 requirements ahead of BSI notified body audits.
- Supported IRB submissions and drafted informed consent documentation, ensuring compliance with regulatory and ethical standards for human subjects' research.
- Participated in internal and external regulatory audits, providing backroom support, scribe duties, and documentation coordination.
- Compiled technical data and documentation for complaint handling and Quality investigations, supporting timely regulatory reporting.
- Assisted in preparing evidence packages for internal and external QMS audits, including training logs, calibration records, batch records, and risk assessments.
Research Scientist II - Thermo Fisher - Fremont, CA
(2021-11 - 2023-02)
Technical File Management, Clinical & IRB Compliance, Change management activities, Quality Management Systems (QMS), IVDR Compliance, Audit Preparation
- Assisted in preparing 510(k) submission documentation, drafting protocols, analyzing performance data, and supporting report generation in accordance with CLSI guidelines.
- Contributed to CMC content for IND submissions by compiling data on formulation development, analytical testing, and stability studies.
- Utilized Agile tools to track regulatory and quality tasks for In Vitro Diagnostic Review (IVDR) submissions, adapting to shifting priorities and deadlines.
- Supported implementation of DEA audit findings into Standard Operating Procedures (SOPs), contributing to ongoing regulatory compliance.
- Managed LIMS-based sample tracking and GMP documentation for formulation and analytical studies, ensuring traceability and audit readiness.
Lab Assistant - California State University, East Bay
(2017-01 - 2019-06)
- Conducted graduate thesis research using HPLC and GC-MS methodologies, maintaining accurate documentation and ensuring reproducibility of results.
- Performed regular equipment calibration and adhered to laboratory safety and quality protocols.
- Independently utilized aseptic techniques in specimen handling supporting student research.
