Regulatory Affairs Specialist - IVDR (In Vitro ...

Regulatory Affairs Specialist II - IVDRLocation: Irvine, CA (Hybrid - Core onsite days Tuesday/Thursday + 1 flexible day)Duration: 1-year contractPay Rate: $45-$50/hour or up to $102,000 a year (subject to experience and IVDR expertise)IMPORTANT: Candidates MUST have hands-on experience with In Vitro Diagnostic Regulation (IVDR). Applicants without direct IVDR experience will NOT be considered.Position OverviewThis role is responsible for supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities impacting all Bio-Rad products currently CE Marked under the IVD Directive. The Regulatory Affairs Specialist II will play a critical, hands-on role in ensuring compliance with IVDR requirements, including technical file remediation, labeling updates, and regulatory tracking.Key ResponsibilitiesLead and support IVDR technical file remediation activitiesRevise and generate technical files using the latest IVDR-compliant templatesEnsure each file clearly demonstrates product characteristics, intended use, and performance to support conformityCompile and verify all required documentation, including technical reports, validations, and test dataDeliver completed technical files within defined project timelinesExecute IVDR labeling conversion activitiesCollaborate cross-functionally to implement labeling updates aligned with IVDR requirementsMaintain and update labeling conversion tracking logs based on manufacturing schedules, lot numbers, and change requestsRevise labeling specifications to ensure full IVDR complianceSupport product lifecycle and compliance activities under IVDRAssist with de-CE marking of selected products and ensure labeling reflects updated regulatory statusTrack and manage RA regional notifications related to labeling changesCoordinate with SAP restriction teams to prevent distribution of non-compliant products in restricted regionsProject tracking and communicationMaintain technical file and project tracking logsParticipate in multiple weekly cross-functional meetingsProvide regular updates to project managers on progress, risks, and issuesRequired Qualifications Hands-on experience with EU IVDR (In Vitro Diagnostic Regulation) is REQUIREDDirect involvement in IVDR transition, remediation, or compliance activities is mandatoryCandidates without IVDR experience will not be consideredBachelor's degree in Biochemistry, Biology, Medical Technology, or related field3-5 years of Regulatory Affairs (RA), Quality Assurance (QA), R&D, Manufacturing, or Project Management experience within the IVD industryStrong understanding of IVD regulatory requirements, technical documentation, and CE marking under IVDRPreferred QualificationsKnowledge of FDA regulatory requirements for IVD productsExperience working in cross-functional, global regulatory environmentsCore CompetenciesAbility to work both independently and collaborativelyStrong communication skills, including the ability to influence and drive alignmentExcellent analytical, problem-solving, and critical thinking skillsProficiency in managing complex documentation and regulatory processes

Created: 2026-05-09