Regulatory Operations Specialist, MDR

05 Jun, 2020

Jobs

Regulatory Operations Specialist, MDR

Teleflex
Chelmsford, MA

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

•    Maintain current worldwide regulatory registrations and device listings
•    Accurate and timely compilation and submission of market authorization submissions and registrations
•    Submission of information to distributors for international product registrations
•    Tech File/Dossier updates and annual reports
•    Post-market reporting and trending
•    Plan, execute and report field actions
•    Facilitate timely impact assessment of proposed changes in worldwide regulatory requirements

Principal Responsibilities

•    Maintain department supplies
•    Prepare product listings,  license translations, Certificates to Foreign Governments and device licenses
•    Maintain credentials for GMDN codes and FDA e-filing services (pertinent to market authorizations and Medical Device Reports)
•    Maintain information in the regulatory market authorization database and prepare reports as necessary
•    Execute SAP transactions to release, hold or end product commercialization; maintain the MA-QAD reference spreadsheet
•    Process market authorization submissions (compilation, e-copy, filing)
•    Update regulatory plans with input from appropriate VSI departments
•    Prepare International (Canada & ROW) product registrations
•    Track all department expenses and prepare monthly credit card reconciliations
•    Schedule and complete Technical File/Design Dossier updates & other annual reports
•    Update department procedures and documentation as needed; submit document change orders
•    Track and report Effectiveness and Efficiency Indicators related to Regulatory Operations
•    Manage GUDID coordinator and labeler accounts for UDI compliance
•    Monitor and assess the impact of emerging regulatory requirements with respect to Regulatory department and company-wide activities; prepare and propose compliance strategies
•    Perform regulatory tasks related to product obsolescence
•    Participate in regulatory agency inspections and audits as needed
•    Assist the VP of Regulatory with identifying and completing department objectives, expense tracking and budget preparations
•    Perform regulatory assessment of distributed product qualifications (including acquisitions) and related changes
•    Perform regulatory assessment of Change Impact Assessments, as needed
•    Carry out other tasks as assigned, including tasks related to the regulatory needs of VSZL

Education / Experience Requirements

•    Bachelor’s Degree in a relevant field
•    Three years of regulatory experience required

Specialized Skills / Other Requirements

•    Well-organized with attention to detail
•    Follows written and verbal instructions
•    Takes initiative; is a self-starter
•    Able to coordinate and prioritize activities
•    Basic database skills
•    Good verbal and written communication skills
•    Efficiently proofreads technical documentation for consistency and formatting
•    Good intra- and interdepartmental collaboration skills
•    Identifies and solves basic problems

 

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.

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Job posted: 2020-06-05