Regulatory Affairs Specialist

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 Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. 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! 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. Maintain current knowledge of regulations and guidance and collaborate with product teams on approvals and disseminate information and generate potential strategies with teams. Support, and coordinate with internal and external resources to meet audit and compliance requirements. Support a culture of continuous improvement by promoting best practices, fostering innovation, and recognizing and celebrating achievements as well as report on key performance indicators (KPIs) to track the progress and impact of continuous improvement efforts. Required/Preferred Education and Experience Bachelor's Degree Relevant Science required Advanced Degree preferred 1 + Years of Regulatory Affairs experience preferably in the medical device industry, with proven experience in electro-mechanical products. required Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Standing

• Occasionally Walking
• Occasionally Sitting
• Constantly Talking
• Occasionally Hearing
• Occasionally Repetitive Motions
• Frequently ZOLL is a fast-growing company that operates in more than 140 countries around the world.

Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives. The annual salary for this position is: This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com. Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.

ADA:

The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com. The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.