Senior Biocompatibility Scientist II

About this role

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott    

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.   You’ll   also have access to:   

Career development with an international company where you can grow the career you dream of   

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.   

An excellent retirement savings plan with high employer contribution   

Tuition reimbursement, the   Freedom 2 Save   student debt   program   and   FreeU   education benefit - an affordable and convenient path to getting a bachelor’s degree   

A company recognized as   a great place   to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune   

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists   

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether   it’s   glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than   10,000 people   have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than   500,000 people   with diabetes from routine   fingersticks .  

Job Description  

As a   Senior Biocompatibility Scientist II , you will play a crucial role in ensuring patient safety by supporting projects and programs related to the biocompatibility of medical devices and materials, including the impact of manufacturing processes.  

You will   represent   the Global Biocompatibility Group within Shared Services as a Subject Matter Expert (SME) in biocompatibility.  

This role involves close collaboration with cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory requirements, including but not limited to the ISO 10993 series of standards, ISO 14971, FDA Biocompatibility Guidance, and Regulation (EU) 2017/745.  

You will   leverage   your specialized knowledge of medical device biocompatibility throughout the product lifecycle and interpret regulatory requirements and guidance governing Class II and Class III devices.  

You will apply biocompatibility requirements and develop evaluation strategies across product development and change management activities.  

Additionally, you will critically review detailed scientific information,   identify   gaps, and assess project risks, recommending contingency plans and strategies to mitigate these risks.  

This role is a senior individual contributor position and does not include direct people management responsibilities.  

Responsibilities:  

• Conduct and document biocompatibility assessments, develop evaluation plans, and prepare reports in compliance with biological evaluation standards and FDA/ISO guidance documents within a risk-based framework.  

• Evaluate design, manufacturing, and site changes, including evaluation of process equivalency and material equivalence, as well as regulatory impact .  

• Collaborate with cross-functional teams to support multiple projects requiring biocompatibility evaluation, ensuring   timely   completion of tasks to meet project schedules.  

• Analyze biocompatibility test results to   determine   data adequacy for biological effects; troubleshoot unexpected results using problem-solving skills and technical knowledge.  

• Assist   with regulatory submissions and prepare responses to questions, nonconformances, and deficiencies from global authorities.  

• Participate in design and risk review meetings to address device biological safety concerns.  

• Maintain comprehensive knowledge of all applicable standards and industry requirements for biological safety, including monitoring updates, ongoing revisions, and upcoming changes to the ISO 10993 series, ISO 14971, FDA guidance, and other relevant regulations.  

• Perform and   assist   with gap assessments when standards, regulations, or guidance are updated to   identify   potential deficiencies in   previous   evaluations   relative   to new requirements; recommend actions to ensure continued compliance and minimize business impact.  

• Participate in the development and implementation of overall biological evaluation strategies in collaboration with colleagues in analytical chemistry, toxicology, and preclinical safety, as applicable.  

• In addition to global regulations pertinent to biocompatibility,   comply with   Abbott policies, procedures, and quality system requirements.  

• Prepare, edit, and   finalize   biological evaluation safety plans, test protocols, lab reports, evaluation reports, synopses, regulatory submission content, and related biocompatibility documents.  

• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.  

Skills and Abilities Required:  

Proficient with MS Office (Word, Excel, Outlook, PowerPoint, SharePoint, OneDrive).  

Strong verbal and written communication skills, with the ability to effectively communicate at multiple levels within the organization.  

Strong technical writing skills, with experience in writing biological risk asse

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