Staff Scientist, Global Biocompatibility

Position Summary

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. 

This position is based at our Morrisville, NC office.  

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 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.
•    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.
•    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.

INDIVIDUAL CONTRIBUTORS: Core competencies of all roles.
•    Commitment to Goals – A strong commitment to achieving goals is essential for personal and team success. It requires taking ownership of tasks, staying focused on priorities, and consistently delivering high-quality work. Being proactive, managing time effectively, and seeking support when needed are critical to meeting deadlines and overcoming challenges. By aligning personal efforts with team and organizational objectives, individual contributors play a vital role in driving results and advancing shared goals.
•    Continuous Improvement - Continuous improvement means actively seeking ways to enhance your work, skills, and contributions. It's critical to stay curious, embrace feedback, and look for opportunities to streamline processes or solve problems more effectively. Individual contributors should take initiative to learn from experiences, adapt to change, and apply new knowledge to drive better outcomes. By consistently striving to improve, they add value to their team and support the organization’s growth and success.
•    Culture and Values – Living our culture and values is essential to fostering a positive, collaborative work environment. Individual contributors demonstrate this by treating others with respect, acting with integrity, and contributing to an inclusive and supportive team culture. It's critical to hold oneself accountable, align actions with shared values, and support the broader mission of the organization. By consistently modeling these behaviors, individual contributors help strengthen the workplace culture and positively influence those around them.

TELEFLEX QUALITY BEHAVIORS:

As a member of the QARA team, you play a critical in our mission to improve the health and quality of people’s lives. Below are the quality behaviors that we expect all QARA employees to exhibit every day.

Patient Focused
•    We prioritize our patients and users in our decision making. 
•    We understand our products and recognize our actions affect product quality. 
•    We understand the impact of product quality on user and patient safety. 
Accountable
•    We show up prepared and if we say we'll do it, we do. 
•    We learn from mistakes and address them quickly.
•    We speak up and take responsibility.                                         
Preventive
•    We proactively look for and address things that could go wrong. 
•    We speak up when we notice poor quality. 
•    We correct poor quality and prevent recurrence.  
Solution Minded
•    We bring solutions to identify problems and are open to change.  
•    We share and implement ideas to continuously improve. 
•    We evaluate fully and investigate to root cause.  

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