Senior Biocompatibility Scientist

Abbott (abbottcareers2 board); United States; On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

HIP PPO medical plan

Generous retirement plan

Tuition reimbursement

FreeU education benefit

Career development opportunities

Job summary

Abbott is seeking a Senior Biocompatibility Scientist in Sylmar, CA to support biocompatibility of medical devices, materials, and processes. You will represent the Global Biocompatibility Group as SME and ensure compliance with ISO 10993 and related FDA guidance across product lifecycles.

You will interpret regulatory requirements, support strategy, and review test plans and risk assessments. Strong collaboration with cross-functional teams is essential.

Qualifications

• Proficient in MS Word, Excel, PowerPoint, Outlook and SharePoint.

Responsibilities

• Prepare and finalize biological evaluation safety plans and reports, synopses and regulatory documents.
• Analyze biocompatibility test results and troubleshoot issues.
• Review and deliver biocompatibility assessments and reports per FDA/ISO guidance.
• Collaborate with cross-functional teams to support multiple projects.
• Assist regulatory submissions addressing biocompatibility strategy.

Skills

MS Office proficiency

Verbal & written communication

Technical writing

Team collaboration

Organizational skills

Job description

JOB DESCRIPTION

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 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Sylmar, CA location.

As a Senior Biocompatibility Scientist , you will play a crucial role in ensuring patient safety by supporting projects and programs related to the biocompatibility of medical devices, materials, and 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, such as ISO 10993.

You will leverage your specialized knowledge of medical device biocompatibility throughout the product lifecycle and your understanding of biocompatibility regulations and guidance affecting Class II to Class III devices. Your responsibilities include interpreting biocompatibility regulatory requirements and supporting the biocompatibility strategy team in applying these requirements to product development and change activities. Additionally, you will critically review detailed scientific information, identify gaps, and assess project risks, recommending contingency plans and strategies to mitigate these risks.

What You'll Work On

• Prepare, edit, and finalize biological evaluation safety plans and reports, synopses, regulatory documents, and related biocompatibility documents, such as testing protocols and laboratory reports.
• Perform and assist with gap analysis of external standards, regulatory requirements, and guidance associated with biological safety evaluation, minimizing negative impacts on Abbott medical devices and business.
• Analyze biocompatibility test results to determine data adequacy for biological effects and troubleshoot unexpected results using problem-solving skills and technical knowledge.
• Review, approve, and deliver biocompatibility assessments, evaluation plans, and reports in compliance with biological evaluation standards and FDA/ISO guidance documents within a risk-based framework.
• Participate in the development and implementation of overall biocompatibility strategies.
• Participate in design and risk review meetings to address device biological safety concerns and ensure proper documentation of biological safety assessments and test plans/reports.
• Collaborate with cross-functional teams to support multiple projects requiring biocompatibility evaluation, ensuring timely completion of tasks to meet project schedules.
• Assist with regulatory submissions to global agencies, elaborating on biocompatibility strategy and data in response to additional information requests.
• Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain a working knowledge of applicable external standards and industry requirements for the biological safety of medical devices.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Assess research results to develop recommendations for future research directions and projects.

Skills and Abilities Required

• Proficient with MS Office (Word, Excel, Outlook, PowerPoint, SharePoint, OneDrive and CoPilot).
• 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 assessments for FDA and Notified Bodies.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong organizational skills with attention to detail and the ability to effectivel