Post Market Reporting Specialist

Date: Nov 23, 2021

Location: Remote, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 5066

 

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

The Post Market Reporting Specialist is responsible for the intake and evaluation of medical device complaints for reporting to FDA and other foreign government agencies, as required, and for submission of the reports.

Principal Responsibilities

•    Manages the day to day activities of the medical device intake, reporting and related processes.
•    Leads the development and maintenance of procedures related to medical device reporting in accordance with 21 CFR Part 820.198, 21 CFR Part 803, ISO 13485, MEDDEV 2.12-1, SOR-98-282 sec. 59, EU MDR and others as applicable.
•    Identifies and leads long-term projects to achieve department objectives related to medical device reporting.
•    Leads recurring stakeholder team meetings to assess complaints for medical device intake and reporting.
•    Completes medical device reportability decision trees and submits medical device reports in required geographies, in accordance with the Company’s procedures.
•    Interfaces with sales reps and customers/patients to gather additional information required for complaint investigations, including the retrieval of product samples.
•    Participates in the complaints investigation and review process, as needed, for medical device reporting.
•    Submits supplemental medical device reports when required.
•    Responds to additional information requests or other regulatory communications related to complaints, medical device reporting, and/or product issues, as necessary.
•    Manages workflows and processes for potentially reportable events within software applications.
•    Supports site audits as necessary to ensure effective implementation of medical device reporting procedures and demonstration of compliance with the procedures.
•    Provides subject matter expert (SME) guidance to internal stakeholders regarding regulations associated with medical device intake and reporting.
•    Provides internal training to others on medical device intake and reportability, as necessary.
•    Maintains current knowledge of worldwide regulatory requirements for medical device intake and reporting.
•    Exhibits professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
•    Carries out duties in compliance with established processes.
•    Performs other duties & projects as assigned.
 

Education / Experience Requirements

•    Bachelor’s Degree required, preferably within the Sciences or the Clinical field, and
•    2-3 years of experience in medical device reporting within the medical device industry.
•    Eight years of experience in medical device reporting acceptable in lieu of bachelor’s degree. 
•    Experience with FDA Quality System Regulations - 21 CFR part 820.198, Part 803, Medical Device Directive, SOR-98-282, EU MDR and MEDDEV guidance documents, associated harmonized standards, ISO 13485, and related quality standards; 
•    Experience with MedWatch and/or fulfillment of international reporting requirements.
 

Specialized Skills / Other Requirements

•    Strong computer skills
•    Strong organizational and analytical skills
•    Ability to interact effectively with sales reps and external customers
•    Attention to detail 
 

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.