Sr. Regulatory Scientist, MDR

Date: Jan 5, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: None

Requisition ID: 3192

 

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 Senior Regulatory Scientist will develop and manage a variety of reports involving clinical data analyses and review, collaborate, and provide clinical research support to cross-functional product development teams, and other functions as necessary.

Principal Responsibilities

•    Develop and manage Post-Market Surveillance Plans (PMSPs), Clinical Evaluation Reports (CERs), Literature Reviews, Clinical Risk-Benefit Analyses (CRBAs), and Summary of Safety and Clinical Performances (SSCPs).
•    Review and support the development of Post-Market Surveillance Reports (PMSRs), Periodic Safety Update Reports (PSURs), Instructions for Use (IFUs), Hazard Analyses (HAs), and other documents, as needed.
•    Develop and manage clinical evidence database, including unpublished reports, publications, and conference communications in support to clinical evidence generation activities and post-market surveillance.
•    Provide clinical research support to project teams, risk analysis teams, and other functions.
•    Provide support to regulatory specialists for submissions or communications with regulatory agencies or notified bodies.
•    Collaborate in pre-market and post-market clinical study activities, including planning, strategy, execution, data analysis, and reporting where necessary.
•    Develop, review and maintain clinical research procedures, ensuring compliance with quality system and external regulations and guidelines.
 

Education / Experience Requirements

•    Bachelor’s degree in biomedical engineering, biological sciences, nursing, or other closely related disciplines 
•    Minimum of five years of experience in the clinical function within the medical device industry.
 

Specialized Skills / Other Requirements

•    Understanding of medical device safety, risk management practices, and adverse effects. 
•    Excellent written communication and demonstrated medical writing and research methodology skills. 
•    Strong verbal and interpersonal skills. 
•    Understanding of clinical study management. 
•    Self-driven with an extremely detail-oriented work style. 
•    Ability to organize, manage, and complete multiple projects. 
•    Proficiency in Microsoft Office Suite. 
 

 

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: Minneapolis