Regulatory Affairs Specialist
Advantage TechnicalIrvine, CA, United States2 days ago
Job type
- Full-time
Job descriptionBachelor’s degree in Biochemistry, Biology, Medical Technology, or a related field. 3–5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry. Familiarity with FDA and CE marking requirements for IVD products is preferred. Strong ability to work independently and collaboratively across teams. Excellent communication skills, including negotiation and persuasion. Proficient in analytical thinking, problem solving, and computer-based documentation. Deep understanding of regulatory policies, procedures, and best practices.
Job Title : Regulatory Affairs Specialist II
Location : Hybrid – Core onsite days are Tuesday and Thursday; third onsite day is flexible Duration : 1 Year Contract - possible extension
Pay Range : $45–$50 / hour
Position Overview
Join our client's Regulatory Affairs team to support the transition to the EU’s In Vitro Diagnostic Regulation (IVDR), impacting all CE-marked IVD products. This role plays a critical part in ensuring regulatory compliance by revising technical documentation, updating labeling, and coordinating regional notifications.
Key Responsibilities
- Technical File Management :
- Revise assigned technical files using the latest templates.
- Ensure each file clearly presents product details, performance expectations, and supporting evidence of conformity.
- Incorporate updated technical reports, validations, and test documentation.
- Complete each file within defined timelines and participate in weekly project meetings to report progress and resolve issues.
- Labeling Compliance :
- Support IVDR labeling conversion efforts through cross-functional collaboration.
- Maintain and update the labeling conversion tracking log based on manufacturing schedules, product fill dates, lot numbers, and change request references.
- Revise labeling specifications to meet IVDR requirements.
- Product De-Registration :
- Assist in un-CE marking selected products.
- Track progress until final labeling reflects required changes per specification documents.
- Regulatory Coordination :
- Update the technical file tracking log.
- Notify and track RA Regional updates related to labeling changes.
- Communicate with the RA SAP restriction coordinator to ensure product lot restrictions are properly implemented.
Qualifications
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Regulatory Specialist • Irvine, CA, United States