RAQA Specialist

Date: Feb 19, 2021

Location: Markham, ON, CA

Company: Teleflex

Expected Travel: None

Requisition ID: 3272 

 

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 Functions The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. 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 RAQA Specialist will primarily be responsible for performing post-market compliance activities of Teleflex Canada. 

Principal Responsibilities

•    Responsible for handling product complaints in collaboration with Teleflex manufacturers, Sales Representatives, and customers. Track reported complaints to ensure timely complaint initiation and closure, analyze complaint reports and provide metrics, coordinate and ship complaint samples when needed, maintain logs, records, and SOP/Work Instruction.
•    Responsible for following current requirements for Mandatory Problem Reporting.  Submit the importer’s MDPRs to Health Canadian in coordination with the manufacturers in an accurate and timely manner, maintain related records and SOP, and respond to inquiries from Health Canada.
•    Perform product hold in SAP system in coordination with the related internal departments to ensure timely and accurate product quarantine and disposition, maintain related records, and SOP.
•    Assist in the implementation of product recalls, follow-up activities, regulatory reporting to Health Canada, and record maintenance.
•    Collaborate cross-functionally with other departments related to products offered by Teleflex Canada and its operations. The related tasks include e.g. determining device class, verifying device licence, product status and availability, reviewing labeling, performing regulatory impact assessments, and responding to various RAQA related inquiries.
•    Perform other duties and support projects as assigned.
 

Education / Experience Requirements

•    University degree and Post-Graduate Diploma in Pharmaceutical Regulatory Affairs and Quality Operation or similar program preferred.
•    Minimum 3 years’ relevant work experience in the medical device industry. High degree of understanding the CMDR and Health Canada guidance.
•    Must demonstrate a high level of attention to detail in completion of tasks and cross-referencing of information in several logs.
•    Must demonstrate strong written and verbal communication skills in English.
•    Ability to multitask, prioritize and work effectively, independently and in a team environment within a multi-disciplined organization.
•    Strong organizational skills and self-motivated in completing tasks and meeting deadlines.
•    Possess verifiable skills in MS Office suite, Adobe, and proficiency with learning and utilizing other applications. SAP user experience is a plus.
 

Specialized Skills / Other Requirements

 

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.