Senior Regulatory Affairs Specialist (MDR)- Remote

Date: Jun 21, 2022

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6606

 

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

Work under the guidance of the Sr. Manager, Regulatory Affairs, MDR to aide in regulatory compliance and approval of Teleflex Medical products across all business units.

Principal Responsibilities

•    Participate on multidisciplinary teams and communicate regulatory requirements effectively
•    Be a central resource for Global MDR regulatory teams.  
    Act a source of knowledge and promote standardized MDR approach through:
-    Creation of road maps to MDR information and guidance documents to aid in submission process
-    Incorporate new learnings into MDR tools / guidance and disseminate to MRD teams
-    Stay abreast of deficiencies and successful responses to update teams to previously accepted responses.
    Act as deployable resources for teams to support:
-    existing reg teams with knowledge of regulations 
-    MDR projects within Business Units
-    response to NB on submissions
•    Investigate and recommend solutions to address potential regulatory issues.
•    Assist internal MDR team members with data analysis.
•    Maintain electronic and paper regulatory files as required by departmental procedure
•    Provide other department support as required by immediate supervisor.
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
 

Education / Experience Requirements

•    Degree; desired four-year college degree in Science or Engineering disciplines.
•    5 years medical device Regulatory Affairs experience
•    Experienced in preparation of Regulatory documentation and submissions
•    Experience with MDR Technical Documents a plus
 

Specialized Skills / Other Requirements

•    Excellent verbal and written communication skills – essential
•    Attention to detail and accuracy.
•    Self-driven and ability to work independently and/or as a team player
•    Knowledge and understanding of US and international medical device regulations, standards, and guidance documents.
•    Good judgement and problem-solving ability; capable of understanding the impact of decision making on both Teleflex Medical and its customers.
•    Effective communicator of issues and able to propose ideas or solutions to senior members of the organization. 
•    Approachable and enthusiastic. 
•    Flexible and adaptable to dynamic project timelines.
•    Good organizational skills with cultural awareness and sensitivity.
•    Goal oriented; displays ownership of results and a drive to achieve.
•    Proficient in Microsoft Office Suite
•    Must be fluent in English.
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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.

© 2021 Teleflex Incorporated. All rights reserved.