Job Description
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Acute Care Technology division of ZOLL develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won’t just have a job. You’ll have a career—and a purpose. Join our team. It’s a great time to be a part of ZOLL! Open to Hybrid / Remote Job Summary Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features. Essential Functions Develop and successfully implement regional regulatory strategies for new and sustaining products/features that result in device approval. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Provide strategic regional regulatory perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s). Work with RA regional and product teams to ensure that regulatory requirements are appropriately considered and accounted for in programs and projects. Author and prepare submittals of IDEs, 510(k), PMAs, Technical Files or Design Dossiers, and other pertinent regional device applications. Work with management on risk assessment and regulatory compliance. Support Cross-Functional NPI Project Teams and provide regulatory guidance. Mai
