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IVDR Regulatory Affairs Specialist
Ref No.: 18-16185
Location: Pomona, California
**Req Intake Attached**

Duration: 6-12 months
Start Date: October 15, 2018
Location: Pomona, CA
Reporting to: Assoc. Director, Regulatory Affairs

Summary:
This position will support a 6 to 12-month project to prepare the company for conformity to EU In Vitro Diagnostic Medical Device Regulation (IVDR).

Role/responsibilities:
• Perform gap analysis for product technical files compared to the requirements in the IVDR.
• Collaborate with other departments to determine action items and deliverables to address gaps.
• Assist with the creation/revision of IVDR procedures, forms and templates.
• Assist with the creation of new tech file template.
• Write technical files per IVDR requirements.
• Correspond with Notified Bodies to obtain certifications.
• Correspond with EU Authorized Representative for product registrations and EUDAMED
• Other tasks may be assigned of a regulatory affairs nature, as needed
Skills needed:
• Excellent organizational skills (must keep track of status of many moving pieces at the same time)
• Good work ethic; ability to work independently (expectation that work will be completed on time with moderate supervision)
• Good technical writing skills
• Good attention to detail
• Ability to read, understand, and summarize technical and scientific information
• Ability to interpret and apply regulations to company policies and procedures
• Proficient in Microsoft WORD, Excel and PowerPoint
• Proficient with electronic document management systems

Experience and Education:
• B.S. or B.A. in a scientific or technical discipline
• 2+ years' experience in Regulatory Affairs or Quality Assurance for medical device and/or in vitro diagnostic device manufacturer
• Prior experience with EU technical files and/or international registrations
• Experience/understanding of the requirements in the current EU IVD Directive and new EU IVD Regulation, a plus