The Scientist I - Biocompatibility will provide highly skilled support for biocompatibility and nonclinical safety evaluations of medical devices, tissue products, and combination products as a part of AbbVie Research & Development. The position will be responsible for supporting cross-functional and cross-site collaborations involving recommendations for biocompatibility activities with limited supervision.

• Responsible for supporting Project Plans for biocompatibility with realistic deliverables with timelines. Actively involved in the planning, execution and management of experimental studies for the safety and efficacy characterization of new and existing products.
• Function as a representative for ISO-10993 (biocompatibility) assessments, with supervision from Biocompatibility senior team members and therapeutic area SMEs.  This will include the design, execution, and interpretation of biocompatibility evaluation strategies per the applicable regulatory requirements, including biological risk assessments and management of required studies and documentation outputs.
• Serve as dedicated biocompatibility resource for product development teams, working closely with other colleagues in Development Science. Provide skilled technical knowledge to support cross-functional project initiatives. 
• Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical devices and other products, including performing gap analysis relevant to changes in biocompatibility standards or guidance.
• Prepare and deliver technical presentations to internal and external stakeholders with minimal supervision. Assist the team in functional training initiatives.
• Works closely with Biocompatibility Team and AbbVie device project teams to generate documentation for regulatory submissions and support regulatory responses. Author and review Biocompatibility documentation for internal and external distribution with minimal supervision. 
• Support global change control activities as they relate to Biocompatibility.
• Build and maintain strong connections and relationships with Contract Research Organizations, Toxicologists and Consultants for Biological Risk Assessments as needed.