Associate Regulatory Affairs Specialist (MDR)- Remote

Date: Jun 21, 2022

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6604

 

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

This entry level position supports the Global MDR group and is required to work effectively with cross-functional groups to aide in communication, tracking, metrics and regulatory compliance and approval of Teleflex Medical products across all business units.

Principal Responsibilities

Assist Regulatory Affairs function, through the following activities:

•    Assist internal MDR team members with data entry and analysis of data.
•    Update and provide metrics for key projects
•    Liaise with various regulatory affairs departments to ensure correct supporting data is provided in a timely manner to requests
•    Support process improvements projects for Global MDR Regulatory Affairs
•    Provide administrative support to Global MDR Regulatory Affairs Management
•    Provide other department support as required by immediate supervisor.
•    Maintain electronic and paper regulatory files as required by departmental procedure
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
 

Education / Experience Requirements

•    1-2 years of professional experience.  Experience in regulated environment preferred.
•    Advanced MS Excel software skills (data management and analysis, VLOOKUP’s, pivot tables, charts, IF statements).
•    Attention to detail and accuracy
•    Excellent organizational and communication skills
•    Fluent English, both written and oral
•    Ability to work well under deadlines and pressure.  Flexible and adaptable to dynamic project timelines.
•    The ability to prioritize tasks and manage several projects and tasks simultaneously 
 

Specialized Skills / Other Requirements

•    Proficient in Microsoft Office Suite
•    Excellent verbal and written communication skills.
•    Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality.
•    Self-driven and ability to work independently and/or as a team player
•    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 
•    Approachable and enthusiastic. 
•    Goal oriented; displays ownership of results and a drive to achieve.
•    Strong organizational skills, multi-tasking, meeting deadlines, and detailed oriented.
•    Eager to learn.
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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.