Biocompatibility Specialist

Expected Travel
:
None

Requisition : 2333

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

The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

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.

• Create a technical document which outlines the applicability of testing on file and/or outlines gaps to address. Work with other functions to determine appropriate sample(s) to produce an efficient and effective remediation plan compliant to MDR 2017/745, ISO 10993, ISO 18562, and other standards or regulations as appropriate to the project.
• Perform gap assessments of products by evaluating device BOMs to determine the applicability of test data to materials of construction. Review of historical data may also include gap assessments for any historical testing that was conducted on an inactive part of ISO 10993.
• Maintain and execute the biocompatibility program/policy for Teleflex Medical to endure all products and processes comply with the regulatory standards.
• Provide input to creating strategies to assure compliance to regulatory standards regarding biocompatibility for Teleflex Medical products.
• Ensure company documentation related to biocompatibility are maintained and updated with most current regulations, standards, and industry practices.
• Provide other departmental support as requested by immediate supervisor.
• Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

• Minimum of a B.S. Degree in B.S. in Biology, Chemistry, Toxicology, Microbiology, or other related field.
• Minimum of 2 years of experience creating medical device biocompatibility evaluations and/or managing biocompatibility projects.

• Strong communication, project management, and technical writing skills
• Biocompatibility Evaluation and Testing Standards Knowledge (ISO 10993, ISO 18562, MDR 2017/745, FDA Guidance 1811, etc.)
• Biocompatibility Testing Knowledge of Methods (analytical chemistry, in vitro and in vivo biology)
• MS Office Experience (word, excel, access, power point)
• Strong problem-solving skills
• Ability to communicate and operate effectively with cross functional teams.
• Adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts

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: .

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, Uro Lift® and Weck® — trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, Uro Lift 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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