ZOLL Medical is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. ZOLL products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of ZOLL employees, and we’re invested in their success.

 We offer competitive salaries and a comprehensive benefits package. Join our team. It’s a great time to be a part of ZOLL!

Job Summary:

The Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. This position will also oversee the preparation, monitor and communicate status of regulatory submissions to appropriate departments.

Essential Functions:

• Manage, direct and support the Regulatory Affairs team. Hire, train, develop, teach, coach, mentor, motivate, discipline, and reward staff members.

• Meet regularly with direct reports to review performance, identify any issues and set expectations of goals.

• Prioritize and plan work activities; adapt for changing conditions.

• Responsible for product submissions license renewals, periodic updates and registrations with domestic and international regulatory agencies.

• Responsible for assembling required documentation for all classes of medical devices; communicate /and give guidance to other departments regarding format and timeline expectation.

• Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval processes.

• Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies.

• Review and approve Engineering Change Orders/Change Requests in accordance with regulatory requirements.

• Lead regulatory compliance activities.

• Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.

• Review, interpret, and report to the head of Regulatory Affairs on product specific regulatory issues.

• Acquire and maintain current knowledge of applicable regulatory requirements.

• Interface with other functional departments to influence efficient execution of projects; provide regulatory support on project teams.

• Manage team of 1-5 regulatory professionals and provide oversight and guidance on regulatory strategies, submissions, and projects.

• Develop and mentor Regulatory Specialists, Senior Specialist and Associates.

• Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s/company’s knowledge of working in a regulated environment.

• Manage team's employee development and succession planning activities; set performance objectives, provide coaching/guidance, and provide performance evaluation.

• Other responsibilities as assigned.