Associate Global Medical Safety Director (Part Time/Remote US)

Expected Travel: Up to 25%

Requisition ID: 11263 

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. 
 
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
 
At Teleflex, we are empowering the future of healthcare.  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

This role will be to ideate, create, promote, institute and monitor workstreams for patient and medical safety across the global Teleflex portfolio reporting directly to the Global Medical Safety Director. As part of the Clinical and Medical Affairs (CMA) function and in partnership with QARA, this position will work with the entire safety team to ensure that the highest patient safety standards are achieved in accordance with our quality commitments.  This role serves as an adjunctive subject matter and technical expert in an area of acute clinical medical practice, research and medical educational programs regarding safety. This role will have an opportunity to work with a global, cross-functional team to make a meaningful difference in patient care through the incorporation of safe and effective use of products and procedural education into medical practice. This individual will be responsible for providing safety and risk input and guidance, both internally and externally, on complex issues and effective education relating to safety, efficacy, clinical research and scientific exchange for existing product indications, precautions and warnings and new products or unsolicited off-label use of FDA and other Competent Authority cleared products. The position with be responsible for providing reactive and proactive medical and clinical knowledge into the responsible product areas throughout the product life cycle and to develop and deliver proactive and reactive communication to relevant internal and external customers. Providing the safety team input on complex issues, development, and execution of strategy for the CMA function, and co-lead cross-functional complex projects. The role provides an expert medical resource to manufacturing, clinical, sales, marketing, R&D, QA/RA, business development, and customers. The role will influence and affect positive outcomes for patients, maintain and improve safety and efficacy and drive greater product acceptance and utilization. Primary responsibility for key physician related activities, education and oversight of field engagements that support scientific objectives across the globe. This position has a fundamental role in overcoming identified barriers through both peer-to-peer communication, education, clinical research support and guidance to internal stakeholders. Serves as a technical resource to manufacturing, clinical investigators, sales, regulatory, education and marketing representatives; gathers input from cross-functional teams and creates plans and programs that improve the understanding, safe and effective utilization of Teleflex products by clinicians and their patients. 

Principal Responsibilities

Quality Assurance and Regulatory Affairs
•    Provide subject matter expertise for discussions of patient complaints and nonconformance to the development and completion of Risk Evaluations, Health Hazard Evaluations, and Event Investigations Files
•    Direct involvement representing Clinical and Medical Affairs on the Product Safety Review Board.
•    Provide subject matter expertise to the completion of Clinical Evaluation Reports and Plan, Post Market Clinical Follow Up, Summaries of Safety and Clinical Performance, Post Market Surveillance, Risk Management Reports as part of the ongoing proactive and reactive reviews of quality and safety.
•    Provide input and update the Global Harms Reference that will be used