Regulatory Affairs Specialist

Agilent seeks a Regulatory Affairs professional to manage global compliance and regulatory submissions for its in vitro diagnostic portfolio. The role ensures adherence to international regulatory requirements across product development, commercialization, and post-market activities in multiple markets including FDA, EU, and Asia-Pacific regions.

Responsibilities

• Prepare and submit regulatory documentation and product registrations for global markets including FDA, IVDR, Canada, and Asia-Pacific
• Compile and maintain regulatory technical documentation including technical files, GSPRs, and conformity assessment reports
• Partner with R&D, Quality, and Commercial teams to integrate regulatory requirements into product development and design control
• Manage post-market activities including Medical Device Reporting, recalls, complaint handling, and post-market surveillance
• Research and interpret evolving global regulations to assess compliance impact and develop remediation strategies

Requirements

• Bachelor's degree or equivalent professional experience
• Minimum three years in medical device, IVD, or regulated industry
• Knowledge of IVD Regulation (EU) 2017/746, NMPA, MFDS, and international standards
• Experience with international submissions across LATAM, EU, Asia, and MDSAP countries
• Proficiency with eQMS platforms such as MasterControl, Veeva Vault, or AssurX
• Strong analytical, communication, and cross-functional collaboration skills
• Antibody-based diagnostics experience strongly preferred