Complaint Reporting MDR/Vigilance Specialist 2

About Teleflex

Teleflex is a worldwide medical technology company focused on improving health outcomes and quality of life. Its portfolio spans anesthesia, emergency medicine, interventional cardiology and radiology, surgical products, vascular access, and urology. The company aims to be a highly trusted healthcare partner through purpose-led innovation and strong products.

Teleflex is associated with brands such as Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck, and the organization emphasizes advancing the future of healthcare.

The Global Operations team is a broad, complex function responsible for end-to-end product fulfillment to customers. It is centered on customer focus, quality, service, and value, and supports continuous improvement across the enterprise.

Role Summary

This role sits within the Complaint Intake & Reporting team and is responsible for evaluating complaints to determine whether they must be reported under applicable regulatory rules, risk documentation, and clinical judgment. The specialist prepares and submits MDR/Vigilance reports to the FDA, Competent Authorities, and other agencies, and gathers any additional information needed during complaint intake. The position also looks for process gaps and improvement opportunities.

Key Duties

• Assess complaint records using clinical knowledge and risk-management documentation to decide adverse event reportability within US, Canadian, and European timelines.
• Follow up with healthcare providers and customers to clarify complaint details and ensure correspondence is properly recorded in the complaint file.
• Prepare and file regulatory submissions such as MedWatch reports for the FDA and vigilance reports for Canadian and European authorities.
• Serve as a clinical point of contact for the complaint management team, helping others understand product use and providing training when needed.
• Enter complaint data accurately in the complaint management system.
• Act as a final reviewer/approver for reporting decisions and initial reports.
• Support audit-related activities and respond to additional-information requests from the FDA and Competent Authorities.
• Help the team meet KPI targets, departmental metrics, and broader QA/RA goals.
• Contribute to improvement initiatives within complaint intake and reporting.
• Assist with wider QMS and risk-management activities as needed.

Experience and Education

A Bachelor of Science degree in Nursing, Biomedical Engineering, or a related science field is required, along with 2 to 5 years of experience in medical devices, healthcare, quality, accreditation, or regulatory work.

Background in post-market surveillance, complaint handling, vigilance reporting, quality, risk management, clinical practice, or healthcare accreditation such as Joint Commission is preferred.

Working knowledge of medical device quality-system regulations, including FDA 21 CFR 820, 21 CFR 803, ISO 13485:2016, MDD, EU MDR, and MDSAP, is expected.

Skills and Competencies

• Strong ability to review information critically and ask for clarification when needed.
• Comfortable handling deadlines, pressure, and shifting priorities.
• Proficient with Microsoft Excel, Outlook, and Word.
• Able to organize tasks effectively and manage multiple assignments at once.
• Capable of learning and interpreting new regulatory requirements independently.

Behavioral Expectations

• Self-motivated and able to work independently or collaboratively.
• Friendly, enthusiastic, adaptable, and flexible.
• Demonstrates sound judgment and problem-solving ability, with awareness of how decisions affect both the company and customers.
• Experience with risk management is preferred.
• Experience in a high-volume complaint environment is preferred.
• Strong organization, time management, influence, and cultural sensitivity skills.
• Excellent spoken and written communication, including the ability to lead meetings.

Additional Information

• Expected travel: up to 10%.
• Requisition ID: 13960.
• The company follows a structured hiring process.
• Unsolicited resumes from agencies or third-party firms are not accepted.
• No unsolicited job offers are made.
• No payment or upfront equipment purchase is ever requested.
• Teleflex is an equal opportunity employer and considers applicants regardless of age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status.
• Applicants who need accommodation during the application process may contact 877-880-8588 or [email protected].
• Teleflex and its product names and logos are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries.
• Copyright © 2026 Teleflex Incorporated. All rights reserved.