Global Biocompatibility Specialist

Date: Sep 2, 2021

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4424

 

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

 

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

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.

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.
•    Facilitate the completion of testing and other required external deliverables in the absence of the Biocompatibility Testing Program Coordinator (back-up). 
•    Train appropriate company personnel on biocompatibility procedures as needed.
•    Ensure company documentation related to biocompatibility are maintained and updated with most current regulations, standards, and industry practices.
 

Education / Experience Requirements

•    B.S. Degree in B.S. in Biology, Chemistry, Engineering, or other related science, with strong chemistry and/or biology background
•    Minimum of 2 years of experience 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)
•    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.


 

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Raleigh