Regulatory Affairs Specialist
Listed on 2025-12-01
-
Healthcare
Medical Science, Medical Science Liaison
Regulatory Affairs Specialist I - Clinical Diagnostics (IVD) — Hercules, CA 94547 | Hybrid (2 days on-site + 1 flexible day after 30 days) | $40/hr | 6-Month Contract - high potential to extend or convert
Join a top-tier biotech and medical manufacturing company at the forefront of clinical diagnostics. The Regulatory Affairs Specialist I will support global product registration and IVDR compliance for in vitro diagnostic (IVD) devices. You will collaborate cross-functionally with Marketing, R&D, QA, and Manufacturing teams to ensure products meet regulatory requirements worldwide. Experience in the IVD industry is essential to support technical documentation, SOP improvements, and global submissions across multiple diagnostic product lines.
WhatYou'll Do
- Assemble regulatory submissions for IVD products across multiple product groups
- Maintain IVDR technical files and monitor change requests
- Support SOP improvements tied to IVDR transition
- Communicate daily with technical writers, publishers, and regulatory teams
- Bachelor's degree in Biology or a related scientific field
- 1+ years in IVD regulatory affairs
- Laboratory research experience in an IVD medical device regulated environment is strongly preferred
- Familiarity with scientific reports, risk management, and Quality Systems
- Proficiency in MS Office and comfort working in electronic systems (e.g., Excel, Word, PowerPoint, Teams)
- Entry level
- Contract
- Quality Assurance and Research
- Biotechnology Research
- Medical Equipment Manufacturing
- Pharmaceutical Manufacturing
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).