Bio-Rad Laboratories · 1 day ago
Regulatory Affairs Specialist II - Temporary
Fort Worth, TX
Full-time
Onsite
Mid Level
$45/hr - $50/hr
3+ years expBio-Rad Laboratories is a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. They are seeking a Regulatory Affairs Specialist II to support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities, including revising technical files and updating labeling to comply with IVDR requirements.
BiotechnologyHealth CareHealth Diagnostics
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 labeling 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
Requires a Bachelor's degree in biochemistry, biology, medical technology or related fields
3-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry
Able to work independently and with others
Communication skills, including negotiation and persuasion
Analytical, problem solving, computer, and critical thinking skills
Thorough knowledge of policies, practices and procedures related to RA
Preferred
Knowledge of FDA, and CE marking requirements for IVD products is a plus
Company
Bio-Rad Laboratories
Bio-Rad Laboratories has played a leading role in the advancement of scientific discovery for over 50 years by providing a broad range of
5001-10000 employees
H1B Sponsorship
Bio-Rad Laboratories 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 (40)
2023 (41)
2022 (56)
2021 (45)
2020 (34)
Funding
Current Stage
Public CompanyTotal Funding
$1.4B2024-02-14Post Ipo Debt· $200M
2022-03-02Post Ipo Debt· $1.2B
1980-03-01IPO
Leadership Team
Christine A. Tsingos
EVP & CFO
Jonathan Divincenzo
President and Chief Operating Officer
Recent News
GlobeNewswire
2026-01-05
2025-12-15
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