Post Market Surveillance Specialist

Date: Jun 1, 2021

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3978

 

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

Responsible for processing incoming product complaints via interface with customers and (Sales/Field Service Representatives and other internal staff) gathers important details of Cardiac complaints and documents information into complaint reports.

Principal Responsibilities

•    Responsible for receiving, collecting, and evaluating data related to product complaints and entering information into the complaint management database.
•    Immediately notify the Manager of Complaint Department of issues that suggest a potential regulatory or business risk.
•    Coordinate the procurement of complaint samples. Prepare and ship return kits.
•    Request and document any additional information needed to thoroughly evaluate and investigate the complaint.
•    Send written or electronic acknowledgement of the complaint to the customer.
•    Complete the Regulatory Decision Tree in the complaint management database.
•    Determine the regulatory Reportability MDR/AE to FDA or other International Regulatory Agencies for each complaint received, in accordance with Teleflex procedures and regulations.
•    Submits Medwatch reports to FDA and Vigilance Reports to Health Canada
•    Performs other duties as assigned.
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, 

Education / Experience Requirements

•    Bachelor's Degree, preferably in Scientific, Healthcare, or related field or High School diploma with 5 years of experience in the medical device industry with QA compliance experience
•    Knowledge of US FDA, MDR and CMDR Regulations preferred.
 

Specialized Skills / Other Requirements

•    Customer service/complaint handling and problem-solving skills
•    Effective verbal and technical writing skills 
•    Exceptional attention to detail
•    Basic computer skills (i.e. word processing, spreadsheets, databases)
•    Documentation, negotiating, time management, and communication skills
•    Ability to work in a team environment and interact with other departments (i.e. Sales and Service, Engineering, etc.)
•    Presentation/training skills
•    Reasoning ability, support and prioritize projects, adapt to shifting priorities, ability to work independently with minimal supervision, able to resolve problems/conflicts independently
 

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.


Nearest Major Market: Boston