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

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/documentation (MDD & MDR) and for ongoing activities related to compliance with Global Regulatory directives and regulations, including MDSAP.
• 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, 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.

Required/Preferred Education and Experience

• Bachelor's Degree in technical or science discipline or equivalent experience required
• 5+ years of regulatory experience in the Medical Device Industry required and
• Experience with medical device regulatory submissions (510(k) or PMA) required and
• Previous experience working with Regulatory Authorities relative to premarket and compliance activities. required and
• Experience with medical device submissions. required

Knowledge, Skills and Abilities

• Project management skills
• Must be able to work under pressure to meet regulatory reporting time frames and company requirements
• Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
• Knowledge of MDSAP and European/International regulations and standards
• Experience interacting with FDA and/or other regulatory agencies
• Must work well in team environments
• Must demonstrate leadership skills in team setting.
• Proven analytical abilities, Able to apply problem-solving skills for problems of moderate to diverse scope
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Understanding of engineering concepts and scientific terminology
• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
• Experience reviewing technical and design specifications
• Superior interpersonal skills
• Excellent communication skills, both oral and written
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Documented evidence of writing skills
• Basic understanding of computer applications
• Familiarity with medical terminology a plus
• Management, leadership and mentoring skills and experience

Travel Requirements

• 10% Some travel is required ~ 10%

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.