Sr RA Executive
Date: 09-Sep-2020
Location: Kamunting, 08, MY
Company: Teleflex
Expected Travel: Up to 10%
Requisition ID: 2563
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.
1. Overseeing preparation of product registration documents and product tender applications for submission to global product registration groups.
2. Review and evaluate technical and scientific data and reports and incorporate them into documents for submission to the US-FDA, EU-NB, Health Canada, JPAL, Malaysia MDA, Australia TGA, Brazilian Authority and other foreign regulatory agencies.
3. Review and evaluate change impact on MDD Technical File and product registration in all related countries. Prepare regulatory assessment.
4. Review transfer product project impact on MDD Technical File and product registration in all related countries. Prepare regulatory plan.
5. Review and approve product labelling to ensure compliance to Regulations of impacted countries. Apply for new Health Canada license and amend existing licenses as requested.
6. Maintenance of updated and revised standards to support compliance of Teleflex Medical product.
7. Participate in R&D projects, changes to existing products and processes and other regulatory /company projects as required. Prepare regulatory strategy.
8. Update and maintain regulatory database.
9. Review and approve marketing pieces i.e. brochures
10. Review and approval of validation protocols/reports and change requests.
11. To comply with requirements of Occupational Safety and Health Act 1994 and other legislative requirements in the workplace.
Bachelor’s Degree in Engineering or equivalent
Minimum 2 years Quality System or Regulatory experience in medical device industry.
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.
© 2020 Teleflex Incorporated. All rights reserved.
