Regulatory Affairs Coordinator (Hybrid)

Date: Jun 16, 2022

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6574

 

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.

 

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. 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 Regulatory Affairs Coordinator is responsible for assisting the Interventional Business Unit Regulatory department with activities necessary for the submission and maintenance of market authorizations and registrations as well as maintaining department metrics for quarterly evaluations. The incumbent will assist with the collection and compilation of information for world-wide applications, financial processing of department invoices, metric measurements, and other duties as needed.

 

 

Principal Responsibilities

•    Prepare and compile registration activities necessary for the timely preparation of regulatory submissions.
•    Assist in producing new or revised medical device submissions in the format consistent with the governing SOPs.
•    Provide administrative support to monitoring of regulatory submission timelines and meeting minutes.
•    Prepare and manage tracking reports of submission activities and other measures for department metrics.
•    With guidance, edit department process documents in support of continuous improvement.
•    Manage department product library.
 

Education / Experience Requirements

•    Associate degree; desired four-year college degree.
•    0 – 2 years office administration
•    0-1 year of experience in a related regulated industry
 

Specialized Skills / Other Requirements

•    Understanding of domestic and international medical device regulations preferred.
•    Excellent verbal and written communication skills
•    Proficient at monitoring multiple activities simultaneously with attention to detail 
•    Knowledge of electronic document management systems and computer office applications
•    Ability to work effectively and efficienly with minimal over-sight
•    Ability to maintain confidential information

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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.

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