Regulatory Affairs Clinical Specialist

Overview

Expected Travel
:
Up to 10%

Requisition : 694

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 Functions — 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.

Position Summary

Responsible for the documentation and reporting of adverse events in the US and Canada in accordance with their regulatory requirements. Reviews complaints to determine reportability based on the regulations and clinical experience with the products.

Principal Responsibilities

• Utilizes clinical experience to review complaints for adverse event reportability in accordance with US and Canadian regulations within required time frames.
• Follows up with health care providers and customers to provide clarification for complaint files and adds correspondence to complaint files as required
• Files Medwatch forms with FDA and Vigilance Reports with Canadian regulatory authorities
• Assists as clinical liason for the complaint management department to facilitate understanding of clinical application for product complaint devices
• Assists with audits and FDA inspections requiring clinical assessment of complaint devices and associated Medwatch reports
• Responds to FDA and Competent Authority for addional information letters
• Uses SAP to perform complaint trend analysis

Education / Experience Requirements

• B.S. Degree in Nursing with demonstrated experience using medical and surgical procedures and their applications

Specialized Skills / Other Requirements

• Strong computer skills utilizing MS Word; SAP a plus

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.

© 2018 Teleflex Incorporated. All rights reserved.