Regulatory Affairs Clinical Specialist
Teleflex

Job Info

Expected Travel: Up to 10%

Requisition ID: 7986

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

Work within Complaint Intake & Reporting team to critically review complaints to determine reportability based on the regulatory requirements, risk documentation and clinical experience. Prepare and submit MDR/Vigilance reports to FDA/Competent Authorities and other regulatory agencies. Where necessary, seek and document relevant additional information in line with the complaint intake process

Principal Responsibilities

Key responsibilities will include (but are not limited to) the following:
• Utilizes clinical experience in conjunction with risk management documentation to review complaints for adverse event reportability in accordance with US, Canadian & European regulations within required time frames.
• Follows up with healthcare providers and customers to provide clarification for complaint files and document correspondence to complaint files as required
• Prepare and submit regulatory reporting documentation such as MedWatch forms with FDA and Vigilance Reports with Canadian and European regulatory authorities
• Assist as clinical liaison for the complaint management department to facilitate understanding of clinical application for product complaint devices and provide training to other team members as required.
• Utilize complaint management system to accurately document complaint information.
• Final Reviewer/Approval of reporting decisions and initial reports
• Support audit activities are required. Assists with responses to FDA and Competent Authority for additional information queries
• Work to meet team KPI's Department Metrics and over QA/RA goals and objectives
• Support improvement projects in the complaint intake and reporting function
• Support wider QMS and risk management activity as required

Education / Experience Requirements

• B.S. Degree in Nursing, Biomedical Engineering, or related science discipline with demonstrated experience in medical procedures - Essential
• Experience in Post-Market Surveillance with experience in Complaint Handling/Vigilance Reporting - an advantage
• Ability to critically review the information and seek clarification
• Ability to work well under deadlines and pressure in a changing environment.
• Skilled in the use of Microsoft suite of applications, i.e., Excel, Outlook, and Word.
• The ability to prioritize tasks and be able to manage several tasks simultaneously.
• Ability to read, understand and self-educate on emerging regulatory requirements.
• Good working knowledge of QMS (Quality Management System) and or RMS (Risk Management System)

Specialized Skills / Other Requirements

• Team Lead PQA Complaint Intake & Reporting
• QARA Snr Manager Global Complaint Intake & Reporting
• Snr Director PQA (Product Quality Assurance)
• Site QA Directors and Management
• VP of QA/RA
• Risk Management Team/QA/RA; Operations; R&D

• Self-driven and ability to work independently and/or as a team player.
• Approachable and enthusiastic. Flexible and adaptable.
• Good organizational skills with cultural awareness and sensitivity
• Good judgment and problem-solving ability & is capable of understanding the impact of decision-making on both Teleflex Medical and their customers.
• Strong collaboration and influencing skills - both internally and externally
• Excellent communication skills - both verbal and written

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.