Regulatory Affairs Systems Specialist

Date: Nov 18, 2021

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: None

Requisition ID: 4549

 

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

The RA Systems Specialist is responsible for managing regulatory processes in Teleflex systems such as Agile and SAP.  These processes focus on global registrations maintenance, global submission status, and regulatory data required by other departments and systems throughout Teleflex.

Principal Responsibilities

Assist Regulatory Affairs Support Function, through the following activities, as required:
•    Manage the global RA submission and request process, including performing the change analyst duties and making key process decisions. 
•    Monitoring the Global Registrations process and providing assistance as needed.
•    Mass loading data into the systems.
•    Respond to regulatory queries and administrative requests, including management of the ACE request process and determination of request next steps.
•    Maintain product listings including FURLS, HPRA etc. 
•    Support process improvements projects for regulatory operations 
•    Update and provide metrics on licenses as required
•    Support with QMS change control activities
•    Liaise with other Regulatory staff and departments to ensure correct supporting data is provided in a timely manner
 

Education / Experience Requirements

•    1-2 years’ experience in QA/RA
•    Attention to detail and accuracy – essential
•    Excellent organizational and communication skills
•    Fluent English, both written and oral – essential
•    Ability to work well under deadlines and pressure
•    Knowledge of electronic document management systems and computer office applications.
•    The ability to prioritize tasks and manage several projects and tasks simultaneously 
 

Specialized Skills / Other Requirements

Preferred: 
•    Understanding of domestic and international medical device regulations
•    Notary public certification
 

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.

© 2021 Teleflex Incorporated. All rights reserved.


Nearest Major Market: Raleigh