Senior Scientist I - Biocompatibility, Tissue Material Sciences

The Sr Scientist I - Biocompatibility is an SME who will support biocompatibility evaluation requests related to marketed products for AbbVie global medical devices.  This includes interfacing with AbbVie manufacturing site change requestors to lead change control activities, organize timely assessments with the biocompatibility team, ensure related documentation regulatory compliance and completion of assessments in change control platforms.  This role requires expertise in ISO 10993, medical device regulations, and formal change control processes/platforms, with a strong focus on technical writing, controlled documentation.

In addition, this individual will be responsible for creation (with minimal supervision) and delivery of biocompatibility training and continuing education for internal stakeholders. Must possess knowledge of ISO-10993 Standards and quality management systems, with prior experience working in in marketed product support ...