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Quality and Regulatory at Bio-Rad

Our Global Quality, Regulatory & Clinical Affairs Team plays a critical role in helping Bio-Rad deliver on its longstanding commitments to quality, innovation, and operational excellence. By meeting customer and regulatory requirements and driving a culture of continuous and sustainable improvement, we help Bio-Rad deliver safe and effective products that advance science and improve human health.    

Bio-Rad employees from various teams share what they value most about Bio-Rad's work culture.

Jennifer explains how the collaborative culture at Bio-Rad has helped her grow her career and develop high-quality products. 

Quality & Regulatory Jobs

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Quality Engineer I - Temporary 잡종 2 - Entry Level 2025-36485 Hercules California United States Hercules, California, United States Quality & Regulatory The Quality Engineer will help facilitate the updating and consolidation of legacy product risk management files related to IVDR.   How You'll Make An Impact: Facilitating risk management assessments, updating risk plans and reports, consolid...
Technical Writer III 잡종 3 - Mid-Level 2025-36548 Irvine California United States Irvine, California, United States Quality & Regulatory As the Technical Writer III, you will provide technical writing for medical device and in vitro diagnostic products to ensure regulatory compliance and customer expectations are met, including but not limited to technical documentations, regulator...
QC Specialist III 필수(현장) 3 - Mid-Level 2025-36517 Irvine California United States Irvine, California, United States Quality & Regulatory As a QC Specialist III, you will operate, maintain, and troubleshoot QC Laboratory instrumentation. Create and release product batch records according to applicable procedures.Evaluate assay runs for accuracy and input data into the appropriate da...
QC Technician II 필수(현장) 3 - Mid-Level 2025-36518 Irvine California United States Irvine, California, United States Quality & Regulatory In this role as a QC Technician II, you will support the testing and documentation needs of the Quality Control department during the manufacture and release of Bio-Rad control products. This position will work both independently and in a team-ori...
Quality Systems Specialist - Temporary 잡종 2 - Entry Level 2025-36506 Irvine California United States Irvine, California, United States Quality & Regulatory This position will support the compilation and maintenance of IVDR technical files, review IVDR and other registration labeling change requests and various quality tasks to support the QMS overall.   How You'll Make An Impact: Review, approve,...
Spécialiste Assurance Qualité CDD 잡종 4 - Senior-Level / Manager 2025-36456 MARNES-LA-COQUETTE France MARNES-LA-COQUETTE, France Quality & Regulatory Vous voulez participer à la qualité de produits qui favorisent la découverte scientifique et contribuent à améliorer la vie des patients ? Vous souhaitez rejoindre une entreprise d’envergure internationale ?   Alors, rejoignez-nous et devenez no...
Supplier Quality Manager 잡종 4 - Senior-Level / Manager 2025-36473 Hercules California United States Hercules, California, United States Quality & Regulatory As a Regional Supplier Quality Manager, the candidate plays a key leadership role overseeing supplier quality and compliance activities across the region. Their day involves collaborating with a team of Supplier Quality Engineers to drive performa...
Lead Auditor 원격 3 - Mid-Level 2025-36432 Seattle Washington United States Seattle, Washington, United States Quality & Regulatory Support Bio-Rad's commitment to quality and compliance by coordinating the internal and external audits as a Lead Auditor/Audit Coordinator. As part of Bio-Rad's Seattle Operations Regulatory Affairs team, you’ll apply your strong leadership skill...
Regulatory Affairs Specialist II - Temporary 잡종 3 - Mid-Level 2025-36484 Irvine California United States Irvine, California, United States Quality & Regulatory Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currently CE Marked under the IVD Directive. Activities include preparation  revision of technical files when needed, update labelin...
Design Quality Engineer 잡종 3 - Mid-Level 2025-36477 Irvine California United States Irvine, California, United States Quality & Regulatory The Bio-Rad Laboratories Design Quality Assurance team located in Irvine, CA, is seeking a detail oriented Design Quality Engineer to support the design, development and maintenance of life science and clinical diagnostics products.  You will work...
Quality Sys Spec I 잡종 2 - Entry Level 2025-36457 Singapore Singapore Singapore Quality & Regulatory The successful incumbent will :   Support ISO 13485:2016, ISO 9001:2015, SS620: 2016 or equivalent for Singapore Distribution Center (Asia Pacific and South East Asia) Support internal Audits Identifies gaps in compliance and takes necessary ac...
Regulatory Affairs Manager 잡종 4 - Senior-Level / Manager 2025-36449 Budapest Hungary Budapest, Hungary Quality & Regulatory The Regulatory Affairs Manager will be responsible for the development, implementation, and on-going improvement of programs in the areas of regulatory compliance, document control, and product registrations/ submissions for the products manufactu...
QC Tech I - Temporary 필수(현장) 2 - Entry Level 2025-36468 Hercules California United States Hercules, California, United States Quality & Regulatory The QC Tech will start the day by printing all the necessary SOP’s for pending QC inspections for incoming raw materials, semi-finished and finished goods. After training is completed, they will inspect these incoming materials (i.e. labels, raw m...
Quality Sys Spec I (fixed term 12 months) 잡종 2 - Entry Level 2025-35984 Singapore Singapore Singapore Quality & Regulatory Primary Role:   The Quality System Specialist (Fixed Term) supports the Quality Management System (QMS) implementation and maintenance in alignment with ISO 9001:2015, SS620:2016, ISO 13485, and GDPMDS requirements. This role is pivotal in ensur...
Quality System Specialist 잡종 4 - Senior-Level / Manager 2025-36258 Budapest Hungary Budapest, Hungary Quality & Regulatory In alignment with Global RA/QA strategic aims, this position manages the Quality Management System for Budapest to ensure the QMS is maintained in compliance with all applicable quality and regulatory requirements. Our new colleague will promote b...
Regulatory Affairs (RA) Specialist 잡종 3 - Mid-Level 2025-36383 Sydney Australia Sydney, Australia Quality & Regulatory A key member of the Regulatory Affairs Function, accountable for providing regulatory affairs knowledge and support the business meeting its objectives, as well as regional RA activities. Delivering product pre market approval within the timefram...
Quality System Specialist III 필수(현장) 3 - Mid-Level 2025-36102 Irvine California United States Irvine, California, United States Quality & Regulatory The Bio-Rad Irvine Distribution Center requires a dedicated Quality System Specialist position to provide the leadership and direction needed to support Global Logistics operations at the facilities including regulatory compliance and the developm...
Quality System Specialist III 필수(현장) 3 - Mid-Level 2025-36080 Richmond California United States Richmond, California, United States Quality & Regulatory The Bio-Rad Richmond Distribution Center requires a dedicated Quality Systems Specialist to provide the guidance and direction needed to support Global Logistics operations at the facilities including regulatory compliance and the development, imp...
QC Supervisor II (Second Shift) Hot Job 필수(현장) 3 - Mid-Level 2024-35731.1 Irvine California United States Irvine, California, United States Quality & Regulatory As the Bio-Rad QC Supervisor, you will oversee the day to day responsibilities around the testing and release of manufactured material. You will interface with multiple departments to achieve product release timelines. Maintain high levels of qual...
BSA, Sr 잡종 3 - Mid-Level 2025-36265 Remote India Remote, India Quality & Regulatory As part of the Global IT Team, this position will lead the harmonization of Quality Management System (QMS) solutions, from a technology perspective, and the implementation and stabilization of Veeva Vault as a global eQMS software solution, worki...
RA Mgr I 필수(현장) 3 - Mid-Level 2025-36164 Taipei Taiwan Taipei, Taiwan Quality & Regulatory Organize RA activities and local QA work to ensure the operation of the company is in compliance with local FDA and other related authorities’ requirements    How You’ll Make an Impact:   Product registration, including new registration, rene...

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