The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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Medical Device, Quality/Risk Management, Submission & Registration, Worldwide Regulatory Affairs
4 Year Degree
The Senior Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in US, Canada, and EU markets including all relevant maintenance activities. This position will also oversee the preparation, monitor and communicate status of regulatory submissions to appropriate departments.
Prioritize and plan work activities in a fast-paced environment; 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 strategy, 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 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 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. Meet regularly with direct reports to review performance, identify any issues and set expectations of goals.
Other responsibilities as assigned.
Required/Preferred Education and Experience:
Bachelor's degree in RA or Regulatory Affairs Certification a plus
10+ years of regulatory experience in the Medical Device Industry
4+ years’ experience with medical device regulatory submissions (510(k), PMA, IDE, DeNovo, etc.)
Previous experience working with Regulatory Authorities relative to premarket and compliance activities
Experience with medical device submissions
Internal Number: RA-002
About ZOLL Medical Corporaton
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!