Senior Scientist I - Biocompatibility, Tissue Material Sciences
Core
Subject Matter Expert supporting biocompatibility evaluation requests and change control activities for AbbVie's global medical devices portfolio.
Role type
Senior Scientist I - Biocompatibility
Builds
Regulatory-compliant change control documentation and training programs for marketed medical devices.
Domain
Medical Devices / Biocompatibility / Regulatory Compliance
Deliverable
client delivery
Required skills
ISO 10993 standards expertise, medical device regulations knowledge, formal change control processes, technical writing, quality management systems, regulatory submissions documentation
Preferred skills
Marketed product support experience, combination product regulations, Good Documentation Practices, Good Laboratory Practices (21 CFR Part 58), CRO interface experience
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 technical presentations on biocompatibility, interface with CROs for project support, author internal procedures and work instructions, hold recurring change control meetings with manufacturing sites
Seniority
Senior, hands-on IC