Senior Scientist I - Biocompatibility, Tissue Material Sciences

About the role

The Sr Scientist I - Biocompatibility supports biocompatibility evaluation requests related to marketed products for AbbVie global medical devices. This role involves leading change control activities, ensuring regulatory compliance, and delivering biocompatibility training.

Responsibilities

• Support on-market products through global change-control activities related to biocompatibility.
• Build and maintain relationships with cross-functional change control requestors at global manufacturing sites.
• Lead change plans for ISO 10993 gap assessments for the organization.
• Review and triage departmental impact assessment notifications.
• Support notified bodies and internal audits regarding ISO 10993 compliance and documentation.
• Maintain knowledge of medical device regulations to ensure compliance and conformance of programs for evaluation of medical devices.
• Prepare and deliver technical presentations to internal and external stakeholders and teams related to biocompatibility, change control, and documentation practices.
• Create a recurring training schedule for biocompatibility and change control.
• Provide skilled technical knowledge to support cross-functional projects and interface with CROs for project support initiatives.
• Interface with AbbVie device project teams to generate documentation for regulatory submissions and support regulatory responses.

Qualifications

• Bachelor's degree or equivalent education and typically 10 years of experience, or Masters Degree or equivalent education and typically 8 years of experience, or PhD with up to 4 years experience.
• Medical device, pharmaceutical, or related experience or experience in a regulated environment with a proven record of success supporting marketed products, including change control processes.
• Significant experience and knowledge of medical devices and combination products.
• Strong technical writing and verbal communication skills; ability to communicate complex technical information clearly and effectively.
• Strong training and education experience.
• Knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations.
• Demonstrate critical thinking and problem-solving skills, including analysis and presentation of data.
• Highly self-motivated and proactive; ability to execute with minimal supervision and direction.
• Possess thorough theoretical and practical understanding of own scientific discipline.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit here. US & Puerto Rico applicants seeking a reasonable accommodation, click here.