Senior Biocompatibility Scientist

About the role

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. This position works out of our Sylmar, CA location.

Responsibilities

• 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.

Requirements

• Proficient with MS Office (Word, Excel, Outlook, PowerPoint, SharePoint, OneDrive and CoPilot).
• Strong verbal and written communication skills