Regulatory Affairs Specialist
Agilent · CA
RegulatoryRemoteFull-time$105k–$164kCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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