Toxicologist, Global Biocompatibility

Date: Jun 2, 2022

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6474

 

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

Responsible for technical leadership and authority for overall toxicological risk assessment strategy supporting all global business units. Will support internal and external activities relating to the toxicology program. Provide value-added partnerships with internal and external stakeholders to biocompatibility, validations for new products, product modification, and product introduction to new markets for Teleflex. Will serve as the Teleflex authority on the results of toxicological risk assessments.

Principal Responsibilities

•    Conduct Toxicological Risk Assessments utilizing appropriate literature review, chemical characterization data, and clinical exposure for relevant patient populations in accordance with ISO 10993, ISO 21726, and ISO 18562 as appropriate.
•    In depth knowledge of hazard identification/biocompatibility testing and risk assessment principles.
•    Provide subject matter expertise for biocompatibility evaluations and/or validations of Teleflex Medical projects: new products and existing product improvement, and new market introductions, gap remediation projects. Develop strategies for new product introductions for US FDA 510(k) submissions.
•    Assist in developing protocols, technical reports, and direct validations, as necessary for biocompatibility studies.
•    Maintain biocompatibility-related procedures current per relevant domestic and international standards.
•    Work closely with Teleflex Medical personnel such as R&D, regulatory affairs, clinical, and marketing in understanding, developing, and executing statistically designed experiments, validations, technical reviews and reports as required for new products, product modification and new market introductions.
•    Provides primary interface and partners with internal and external analytical laboratories on the chemical characterization.
•    Works on assigned projects with limited supervision. Responsible for the timely completion of technical deliverables.
•    Assesses the biological safety impact from manufacturing and supplier changes on patient-contacting devices.
•    Consults on the biological safety impact from device field issues.
•    Mentors/leads biocompatibility specialists in hazard identification/biocompatibility testing and risk assessment principles.
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.

Education / Experience Requirements

•    B.S., M.S., or Ph.D. (Chemistry, Biology, Toxicology, or related field). 
•    Certification as a Diplomat of the American Board of Toxicology (DABT), ERT, or equivalent -essential required
•    In addition to the above certification, 1-2 years of experience in biocompatibility, chemical characterization, medical device/pharmaceutical toxicology is preferred.
•    Broad experience in biological/toxicological assessments.  
•    Supervisory/management experience a plus

Specialized Skills / Other Requirements

•    Regulatory, cGMP knowledge base 
•    Able to apply advanced scientific principles
•    Able to work on cross-functional teams with ability to influence without authority
•    Excellent oral, written communication skills and presentation skills. Ability to creatively solve complex problems
•    Computer skills and software development, (i.e., data-base development, LIMS, statistical software and analysis, word processing for report generation, etc.)
•    Ability to operate and communicate effectively with multiple teams
•    Knowledge and experience in Biological, Toxicological, and/or Chemical Evaluations focused on demonstrating safety with a commitment to quality.
•    Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts 

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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.

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