What are the responsibilities and job description for the Regulatory Affairs Specialist II position at Radiant Systems Inc?
Title: Regulatory Affairs Specialist II – Hybrid
Location: 9400 Jeronimo Rd, Irvine, CA 92618
Duration: 12 months
MAX PAY RATE: $45.00/hr. - $50.00/hr.
Key Skills: Regulatory Affairs, Labeling, IVD, IVDR, CE Marking, In Vitro Diagnostics
Work Schedule: Hybrid (3 days a week; Core days: Tuesday/Thursday, with an optional third onsite day)
Role Overview:Support the EU In Vitro Diagnostic Regulation (IVDR) transition activities, specifically for products currently CE Marked under the IVD Directive. This includes tasks such as preparing and revising technical files, updating labeling to comply with IVDR requirements, tracking RA regional notifications, and related activities.
Key Responsibilities:- IVDR Technical File Support: Revise assigned technical files in accordance with the latest template to ensure they clearly present product details, characteristics, performance, and evidence of conformity. Complete technical files within predefined timelines. Attend weekly meetings to address technical file issues and report progress to the project manager.
- Labeling Conversion Project: Participate in the IVDR labeling conversion project, including weekly group meetings and maintaining an updated tracking log. Ensure labeling specifications meet IVDR requirements and are aligned with the product’s manufacturing schedule and lot numbers.
- CE Marking and Labeling Updates: Support the process of un-CE marking selected products and track changes until the final labeling reflects the desired updates. Manage technical file and labeling change notifications to RA regions and SAP restriction coordinators.
- Miscellaneous Activities: Update technical file tracking logs, monitor RA Regional notifications, and notify the SAP restriction coordinator when specific product lots need to be restricted for distribution in certain regions.
- Education: Bachelor's degree in biochemistry, biology, medical technology, or a related field.
- Experience: 3 years in Regulatory Affairs (RA), Quality Assurance (QA), Research and Development (R&D), Manufacturing, or Project Management in the IVD industry.
- Knowledge: Familiarity with FDA and CE marking requirements for IVD products is a plus.
- Skills:
- Strong communication skills, including negotiation and persuasion.
- Analytical, problem-solving, computer, and critical thinking abilities.
- Thorough knowledge of RA policies, practices, and procedures.
Salary : $45 - $50