Katalyst CRO · 20 hours ago
Regulatory Affairs Specialist
Irvine, CA
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is seeking a Regulatory Affairs Specialist with expertise in FDA and CE marking requirements for IVD products. The role involves preparing and revising IVD technical files, updating labeling to comply with IVDR requirements, and tracking regulatory notifications.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Support the IVDR project by revising the assigned technical files
Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity
Each technical file must include the latest version of the required technical reports, validations, test reports and other documents listed in the technical file table of contents which are an integral part of the technical file
Each assigned technical file must be completed within a pre-defined timeline
Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical files and keep the project manager informed on the progress of the work
Support the IVDR labelling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan
Update the labeling conversion tracking log based on the monthly manufacturing schedule, the product fill dates, the associated product lot numbers and change requests numbers
As needed, update labeling specifications to meet the IVDR requirements
Support the tasks to un-CE Mark selected products and track the work until the final labeling reflects the desired changes based on the labeling specification document
Other miscellaneous activities will include updating the technical file tracking log, notifying and tracking RA Regional notifications of labeling changes, and notifying the RA SAP restriction coordinator when specific product lots need to be restricted to prevent distribution of the product in specific areas of the world
Qualification
Required
MUST HAVE IVD (In-vitro Diagnostics)
Requires a bachelor's degree in biochemistry, biology, medical technology or related fields
2-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry
Knowledge of FDA, and CE marking requirements for IVD products
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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