Clinical Risk Project Manager

Our client, a leader in the medical device industry, is seeking a dedicated and experienced Clinical Risk Project Manager to join their dynamic team. As a vital part of the Clinical Affairs department, you will support cross-functional teams to ensure the safety and regulatory compliance of medical devices throughout their lifecycle. The ideal candidate will demonstrate strong analytical skills, excellent communication, and a collaborative spirit, aligning seamlessly with the organization’s commitment to innovation and excellence. Job Title: Clinical Risk Project Manager Location: Santa Clara, CA, Sylmar, CA, Plano, TX, St. Paul, MN, or possibly remote (onsite visits required for equipment pickup and meetings) Duration: 9+ Months with highly possible extension / conversion What's the Job? Lead and participate in clinical risk evaluation processes for medical device products. Create and maintain comprehensive Risk Evaluation Files (REFs) to document clinical risks and safety information. Facilitate Risk Alignment Committee (RAC) meetings, engaging cross-functional stakeholders to ensure alignment and informed decision-making. Interpret and evaluate clinical safety data from various sources, including investigations, post-market experiences, and scientific literature. Support global regulatory submissions and ensure ongoing communication with regulatory teams to address clinical risk disclosures. What's Needed? Minimum of 5+ years of experience in healthcare, clinical research, medical writing, or related fields within the medical device or pharmaceutical industry. Previous experience working in the medical device industry with understanding of clinical research and regulatory guidelines. Strong analytical, critical thinking, and technical writing skills. Bachelor’s Degree (advanced degrees in medicine, nursing, or biomedical sciences preferred). Ability to manage multiple projects efficiently in a fast-paced environment, with excellent communication skills. What's in it for me? Opportunity to contribute to innovative medical device safety and compliance initiatives. Work with a collaborative and forward-thinking team dedicated to excellence. Potential for contract extension based on performance and project needs. Engage in meaningful work that impacts patient safety and healthcare outcomes. Flexible work arrangements with onsite and remote options to support work-life balance. If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you! #J-18808-Ljbffr