Regulatory Specialist (MDR/IVDR)
Irvine, CA 92618 (*Local candidates- 3 days on site/2 days remote)
$40-$45hr (Weekly pay + Benefits)
1yr contract (Excellent potential for extension or permanent)
Full-time- M-F 8am-5pm
Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives. 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 labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities.
How You’ll Make An Impact:
Support the IVDR labeling conversion and revisions of technical files for all Bio-Rad Irvine products that are due to convert from the IVD Directive requirements to the new IVD Regulation.
Work cross-functionally in weekly meetings to ensure the labeling conversion follows the plan.
Monitor the monthly manufacturing schedule, track change requests, monitor manufacturing timelines and update the labeling tracking log to ensure accuracy of the associated product lot numbers, RA Regional notifications, RA Regional follow-ups and product restrictions, as required.
Update previous revisions of IVDR Technical Files to the latest template and include all the necessary attachments.
What You Bring:
Requires a Bachelor's degree in biochemistry, biology, medical technology or related fields
2-8 years of experience in Regulatory affairs, in Quality Assurance, (R&D), Manufacturing, Project Management in IVDR (Vitro Diagnostic Regulation) OR MDR ( Medical Device Reporting)
Requires IVDR experience Or MDR ( Medical Device Reporting)
Must have knowledge of FDA, and CE marking requirements for IVD products i or medical device s a plus
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.
