Job Title

OverviewRegulatory 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 convertJoin 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.What You'll DoAssemble regulatory submissions for IVD products across multiple product groupsMaintain IVDR technical files and monitor change requestsSupport SOP improvements tied to IVDR transitionCommunicate daily with technical writers, publishers, and regulatory teamsWhat You BringBachelor's degree in Biology or a related scientific field1+ years in IVD regulatory affairsLaboratory research experience in an IVD medical device regulated environment is strongly preferredFamiliarity with scientific reports, risk management, and Quality SystemsProficiency in MS Office and comfort working in electronic systems (e.g., Excel, Word, PowerPoint, Teams)Seniority levelEntry levelEmployment typeContractJob functionQuality Assurance and ResearchIndustriesBiotechnology ResearchMedical Equipment ManufacturingPharmaceutical Manufacturing #J-18808-Ljbffr