Safety Manager in United States Of America Remote Based

Job Title Medical Safety Manager - Ultrasound Job Description Medical Safety Manager, Ultrasound The Medical Safety Manager independently oversees safety surveillance activities for medical products by analyzing data from post-marketing surveillance, literature reviews, and real-world evidence to identify risks and ensure patient well-being. The role supports regulatory compliance through the preparation of safety-related documentation, including Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports. Your role: Independently conducts comprehensive safety evaluations using data from post-marketing surveillance, literature reviews, and clinical trials to proactively identify and assess potential risks and safety signals. Provides critical safety insights and recommendations for risk management activities, including Health Hazard Evaluations, Risk-Benefit Analyses, and recall procedures, ensuring robust patient safety measures are in place. Supports New Product Introduction, clinical studies, and post-marketing efforts by delivering safety-related perspectives and collaborating on safety inputs for regulatory submissions and key documentation such as RBAs, protocols, Clinical Study Reports, and Clinical Evaluation Reports. Responds to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust through transparent communication and supporting the implementation of safety policies, procedures, and programs to promote a culture of compliance. Stays current with evolving medical product safety regulations and guidelines, offering input into the design and execution of safety studies and vigilance activities to ensure adherence to requirements throughout the product lifecycle. You're the right fit if: You’ve acquired 5&#43

Job Title Medical Safety Manager, Hospital Patient Monitoring Job Description Medical Safety Manager, HPM The Medical Safety Manager, Hospital Patient Monitoring is responsible for conducting comprehensive evaluations of safety information sourced form a variety of channels such as Post-Marketing Surveillance (PMS) and literature searches, working under limited supervision. Your role: Provides essential support in bolstering patient safety by actively contributing insights and recommendations to critical processes such as Risk Management, Health Hazard Evaluations (HHE), Risk-Benefit analyses, and recall procedures. Offers valuable assistance in delivering safety-related perspectives for New Product Introduction (NPI) projects, clinical studies, and Post-Marketing Surveillance (PMS) efforts, facilitating informed decision-making. Collaborates effectively to furnish pertinent safety inputs for regulatory submissions and key documents such as Risk-Benefit Analyses (RBA), protocols, Clinical Study Reports (CSR), and Clinical Evaluation Reports (CERs), ensuring compliance and transparency in safety evaluations. Conducts literature reviews and surveillance activities to identify emerging safety issues, ensuring proactive identification and mitigation of potential risks. Provides answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders, fostering trust and transparency in communication regarding product safety. Contributes to the implementation of safety-related policies, procedures, and programs to promote a culture of safety and compliance within the organization. Maintains awareness of evolving regulations and guidelines related to medical product safety and ensures compliance with applicable requirements. Provides input into the design and conduct of safety studies and medical device vigil

Job Title Field Service Engineer - Medical Imaging (Metro NYC / Tri-State Area) Job Description Field Service Engineer - Medical Imaging (Metro NYC / Tri-State Area) You will be responsible for customer relationship management through the effective use of technical knowledge to install, troubleshoot, service, and maintain equipment at customer sites nationally. The ideal candidate will be able to travel nationally but will be located in the greater New York City area. We expect this FSE to live within a 45-minute commute to Manhattan, with travel to other sites as required. Your role: Deliver exceptional customer service by setting clear expectations, meeting commitments and arrival times, and resolving customer issues efficiently. Build strong customer relationships by understanding their business environment while contributing to service revenue growth. Collaborate as an active member of the regional team to improve processes, identify training gaps, and share best practices. Continuously expand capabilities by learning new tools and becoming qualified across multiple modalities as needed. Complete all required administrative and compliance tasks in accordance with company, state, and federal regulations. This includes accurate documentation for timesheets, service work orders, expense reports, PMs, FCOs, installations, and adherence to quality and safety standards. Diagnose and resolve electronic, mechanical, and network-related system issues using established tools, resources, and escalation processes. Perform preventative maintenance, field changes, installations, and corrective service within required timeframes. Travel extensively (approximately 90%) with the ultimate focus being in the assigned territory to support customer sites, but will require overnight stays and air travel nationwide