Regulatory Affairs Specialist

Date: 25-Jul-2022

Location: Kamunting, 08, MY

Company: Teleflex

Expected Travel: None

Requisition ID: 6828

 

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

Principal Responsibilities

1.    Manage Technical Documentation
2.    Manage product registration, tender and license applications
3.    Use technical writing skills to clearly describe technical information 
4.    Review and assess of change control activities for potential impact on current regulatory filings and prepare regulatory assessment as appropriate. 
5.    Manage updates to global regulatory procedures and maintenance of Regulatory procedures to ensure continued compliance.
6.    Ensure continual Quality System compliance by adherence to established and evolving internal requirements.
7.    Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management as they relate to registration and commercialization of medical devices to impacted countries.
8.    Support Regulatory inspections at the site as directed.
9.    Liaise with other departments to ensure correct supporting data generated and provided in a timely manner.
10.  Review and approve product labelling to ensure compliance to Regulations of impacted countries. 
11.  Undertake effective OSH measures to ensure compliance, within the workplace, with the Occupational Safety and Health Act 1994 and other legislative requirements.
 

Education / Experience Requirements

Qualification    :    
Bachelor’s Degree in Science/Engineering or equivalent

Experience    :    
Minimum 2 years Regulatory and Quality System experience in medical device industry
 

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.