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Form of workJob Description
Regulatory Affairs Specialist I
Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad Irvine products currently CE Marked under the IVD Directive. Activities include preparation of new IVDR Technical File, revision of technical file when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities.
Summary:
- Provide regulatory support for Bio-Rad products that will be transitioning from the IVDD to IVDR CE Marking.
- Collaborate with cross-functional groups (e.g., Quality Assurance, Research & Development, Marketing) to collect and coordinate information and regulatory documentation to assemble IVDR compliant technical files.
- Update IVDR Labeling Conversion Log, assure all documentation is prepared and processed timely to meet the manufacturing schedule. Assist in the generation of Change Requests for product labeling according to Labeling conversion plan.
- Communicate and assist in the notification process to all International Regional RAs. This may include sending the notification, logging regional responses and tracking RA Regional activities to completion. Ensure product restrictions are implemented, as required.
- Perform other IVDR or regulatory related duties as required or assigned.
Requirments:
- 0-2 years of experience in Regulatory Affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry
- Working knowledge of FDA, and CE marking requirements for IVD products is a plus
- Able to work independently and with others
- Able to work with minimal supervision
- Excellent computer applications skills
- Strong customer orientation and focus
- Effective communication skills, both written and oral
- Strong documentation and organizational skills
- Strong tact and negotiation skills
- Excellent people skills
