Staff Scientist, Global Biocompatibility

Principal Responsibilities

• Create Biocompatiblity Evaluations, determine rationales and test strategies to address the appropriate endpoints to ensure safety and comply with the relevant regulatory standards appropriate to the geographic region(s).
• Collaborate with project teams to determine requirements that may be needed to aid in project feasibility decisions.
• Work with Engineers, Scientists, Regulatory Affairs and other cross-functional team members to ensure the strategy for biological assessment is comprehensive and appropriate for scope of the project.
• Participate in gap assessments for any changes made in relevant standards documents.
• Primary point of contact for all assigned Project Teams, to provide clear and concise updates regarding the timing of all deliverables, updates as needed, and prompt notification of changes or unplanned activities that could impact the project.
• Outline testing plans and specifying the appropriate sample selection, as needed.
• Train appropriate company personnel on biocompatibility procedures as needed.
• Ensure company documentation related to biocompatiblity are maintained and updated with most current regulations, standards, and industry practices. Have proactive understanding of industry expectations and updates to standards.
• Indirectly mentor and develop technical staff (Biocompatibility Specialists).
• Demonstrate awareness of overall global Teleflex vision and priorities; Create and implement new technologies and concepts to impact business; Implement and facilitate changes. Assume specific responsibilities for departmental operations, if needed.
• Develop and provide training to global Teleflex employees on key topics.
• Adhere to and ensure compliance with the Teleflex Code of Ethics, all company policies, rules, and procedures.
• Complete other duties and tasks as assigned.

Education / Experience Requirements

• Bachelor’s degree in Biology, Chemistry, Engineering, or other related science, with strong chemistry and/or biology background required. Master’s degree or PhD preferred.
• Minimum of 5 years of experience, with a bachelor’s degree, creating medical device biocompatibility evaluations and managing biocompatibility projects.
• Minimum of 3 years of experience, with an advanced degree, creating medical device biocompatibility evaluations and managing biocompatibility projects.

Specialized Skills / Other Requirements

• Expertise and knowledge in regulatory requirements for biocompatibility (ISO 10993, ISO 18652, CFDA, EU MDR, MHLW, GLP, GMP, ISO 17025, etc).
• Biocompatibility Testing Knowledge of Methods (analytical chemistry, in vitro and in vivo biology).
• Working knowledge of applying basic toxicology methodology (e.g. threshold of toxicological concern, selecting points of departure, estimating exposure dose).
• Demonstrated proficiency in MS Office (Word, Excel, Access, PowerPoint, Outlook, SharePoint).
• Strong communication skills (written and verbal).
• Ability to communicate and operate effectively with multiple teams.
• Negotiation and strong problem solving skills.
• Able to define, organize, and manage individual tasks.
• Able to create and review technical documentation.
• Interpersonal skills; working in a team and as an individual contributor.
• Foster a positive culture of growth, collaboration, and achievement across the organization.