Senior Scientist, I: Biocompatibility
Core
Subject Matter Expert supporting biocompatibility evaluation requests for marketed medical devices, leading change control activities, and ensuring regulatory compliance.
Role type
Senior Scientist, Biocompatibility (Marketed Product Support)
Builds
Regulatory compliant documentation and change control assessments for global medical devices
Domain
Medical Devices / Biocompatibility / Regulatory Compliance
Required skills
ISO 10993 standards, medical device regulations, change control processes, technical writing, quality management systems, regulatory submissions, Good Documentation Practices, Good Laboratory Practices
Preferred skills
Combination product regulations, CRO management, training development, cross-functional collaboration
Technologies
Electronic Data Management Systems, change management platforms
Responsibilities
Lead change plans for ISO 10993 gap assessments, review and triage impact assessment notifications, prepare and deliver biocompatibility training, interface with CROs for project support, generate documentation for regulatory submissions
Seniority
Senior, hands-on IC