Patient Safety Associate

For over 65 years, Gore has improved lives through discovery, product innovation and rewarding careers for Associates. We push the boundaries of what's possible — not just through our products and technologies but also through individual growth and development. We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. Our Associates build on a rich history of innovation, upholding Gore’s values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

We are looking for a Patient Safety Specialist to join our Office of Medical Affairs team. In this role, you will provide healthcare provider perspective, medical expertise and judgment, and objectivity in review of patient and medical device safety matters and act as an independent patient safety advocate for all products within a product category. This is a remote position, and you can work from home in most locations within the United States.

Process participant for pre- and post-market safety activities, including risk management, clinical study adverse event review, product launches, product surveillance, and quality investigations Provide healthcare provider perspective on benefit / risk questions. Ensure appropriate and adequate assessment and disclosure of medical risk. Ensure accurate and balanced presentation of human clinical data from a medical perspective including in regulatory reporting efforts and promotional materials Provide medical judgment to assist in select regulatory, clinical investigation, compliance, or legal matters. Serve as a reviewing and refining resource and provide in-depth and compositional support as needed while ensuring proposed changes adequately address clinical considerations. Establishing functional expertise and serving as subject-matter expert for safety processes Maintain compliance with training expectations as required for this position Additional responsibilities as required within the scope of position