Staff Scientist, Global Biocompatibility

Teleflex•Durham, NC

About The Position

This role is responsible for creating biocompatibility evaluations and overseeing testing activities as necessary to support a variety of projects related to R&D and design control changes, as well as special projects. This will require review of historical testing data in a variety of databases to determine applicability per appropriate international standards, documenting rationales and testing requirements, and ensuring that the project is executed appropriately to maintain compliance and ensure patient safety as it relates to biocompatibility. This role will also exhibit thought leadership in regulatory strategy as well as entry level understanding of toxicology principles.

Requirements

B.S. Degree in B.S. in Biology, Chemistry, Engineering, or other related science, with strong chemistry and/or biology background. 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.
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
Ability 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.

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 feasiblity 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