Regulatory Affairs Specialist, Morrisville

Date: Jan 5, 2021

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3112

 

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.

 

Anesthesia and Emergency Medicine - At Teleflex, we promote the use of advanced anesthesia and emergency medicine techniques to help improve outcomes and reduce healthcare costs. Through collaboration with global clinical experts, we lead the way in the development of technology, clinical research and education to improve practice in a meaningful way. Today, our LMA® and Rüsch® brands include some of the most advanced airway management devices on the market. The Arrow® portfolio of pain management products is designed to improve patients’ post-operative pain experience. And our Arrow® EZ-IO® System helps address the time-critical challenge of emergency intraosseous vascular access. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

This Morrisville, NC based Regulatory Affairs Specialist will develop strategies and submissions for Teleflex Medical’s Anesthesia and Emergency Medicine business. Submissions will be globally based for our medical device products, and include devices in airway, emergency medicine, pain management and mucosal atomization products. Submissions will be at moderate to complex level, and relate to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The incumbent is also responsible for staying abreast of evolving global regulatory requirements.

Principal Responsibilities

•    Develop regulatory strategies for product development and launch of moderate-complexity projects.
•    Review and assess of change control activities for potential impact on current regulatory filings.
•    Ensures compliance with design controls and reviews design documentation to ensure that it follows the regulatory requirements.
•    Interpret existing regulations and guidance documents within regulatory department and on project teams.
•    Provides a regulatory expertise and oversight to design teams.
•    Identify risk factors and contingency planning for assigned projects.
•    Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance.
•    Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks.
•    Interfaces as needed with FDA, Notified Bodies or other national health agency regarding new products and significant changes to products.
•    Assume full responsibility for project submissions, from guidance/strategies/authoring/obtaining approvals, including 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required for registration/licensure of products outside the U.S. 
•    Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information.
•    Review and approve all labeling (product, advertising and promotional) verbiage.
•    Understand and communicate regulatory processes, guidelines and guidance documents and what they mean to the organization.
•    Apply understanding of the quality systems to job activities and projects.
•    Participate in training RA team members and others on compliance matters.
•    Brings Regulatory Affairs questions/issues to the attention of RA management.
•    Prepares monthly reports to RA management.
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

 

Education / Experience Requirements

•    A bachelor’s degree in a science or engineering field is required.  
•    Regulatory affairs experience preferred in domestic and international submissions, with 2-3 years of overall class I or II medical devices. 
 

Specialized Skills / Other Requirements

•    Strong communication skills (verbal and technical writing)  
•    Strong attention to detail  
•    Strong analytical and critical thinking skills  
•    Ability to organize, prioritize, manage multiple projects and meet deadlines  
•    Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality  
•    Knowledge of electronic document management systems 
•    Ability to apply Business and Regulatory Affairs ethical standards  
•    Proficiency in MS Word, Excel, Power Point, and Outlook 
 

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: 262-439-1894.

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.


Nearest Major Market: Raleigh