MDR Biocompatibility Specialist

Date: 21-Feb-2021

Location: Kulim, 02, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 3381

 

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

Oversee all MDR gap assessments of biocompatibility data for Teleflex Medical products.   Review historical testing data in a variety of databases to determine applicability per the new MDR initiative.  Produce a technical document summarizing the applicable testing and/or identifying remediation plans when gaps are detected.

Principal Responsibilities

  • 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.
  • 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 sterilization and microbiological controls are maintained and updated with most current regulations, standards, and industry practices.
  • Perform miscellaneous projects and duties as assigned.
  • Adhere to and ensure the compliance of Teleflex Medical Code of Conduct, all company policies, rules, procedures, and housekeeping standards.

Education / Experience Requirements

  • B.S. Degree in B.S. in Biology, Chemistry, Microbiology, or other related science.
  • Minimum of 2 years of experience performing or reviewing medical device biocompatibility test reports.

Specialized Skills / Other Requirements

  • Strong communication and technical writing skills
  • Biocompatibility Evaluation and Testing Standards Knowledge (ISO 10993, ISO 18562, MDR 2017/745, FDA Guidance 1811, etc.)
  • MS Office Experience (word, excel, access, powerpoint)
  • 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.

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time. 

Teleflex is an equal opportunities employer

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.