Label Change Analyst (Contract)

Date: 13-Jan-2022

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 4486


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


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

Principal Responsibilities

•    Execution of MDR labelling project in Teleflex Kamunting 
•    Raise Project Brief in Veraciti for labelling changes related MDR requirements, coordinate the contribution by Functional Owner and then sign off the Project Brief.
•    Support preparation documentation of the revised draft FPS, Labelling checklist, PCO 
•    Prepare and verify master data load files with required data updates for each Label Change Order (Bill of materials, IPN and GTIN information etc).
•    Redline the IFUs changes required to meet MDR requirements and liaise with IFU supplier for amendment.
•    Perform proofing of revised IFU and coordination of the IFU approval process  
•    Raise Change Request Form (COF) and coordinate COF approval process 
•    Liaise with Planning/Material teams the implementation date of the COF

Education / Experience Requirements

Preferably recognized degree in related discipline 
Possesses a good command of English, written and oral
Good communication skills
Computer literate

Attention to detail and accuracy – essential
Ability to work well under deadlines and pressure
The ability to prioritize tasks and able to manage several project tasks simultaneously 
Able to work on own initiative and as a team player

Specialized Skills / Other Requirements

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.