Regulatory Affairs Specialist
Newark, DE 19702
12 months contract to start with (extendable contract)
Description
• Represents RA on design change projects.
• Communicates regulatory strategy to project teams in the development of verification plans which will enable successful registration of IVDs in U.S., EU, Japan and worldwide.
• Utilizes FDA guidance documents and historical knowledge to develop and implement regulatory strategy ensuring compliance with FDA requirements. Writes notes-to-file and submits CLIA categorization requests.
• Prepares dossiers and technical explanations to successfully register IVDs in countries worldwide including Latin America, Asia Pacific, Middle East countries.
Requirements
• BA/BS in Science, Engineering or related discipline or advanced degree.
• 3-6 years of experience in regulatory affairs.
• Experience on project teams representing RA and bringing new products to market.
• Knowledge of and experience with FDA regulations and design control requirements for medical devices with preference for IVDs.
• Knowledge of and experience with global regulatory requirements for medical devices or IVDs.
• Experience reading technical reports.
• Experience in a laboratory environment is helpful (e.g., Med Tech background)
Thanks & Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
510-402-4704 (Voice & Text)
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com
linkedin.com/in/imranshikalgar