Medical Device, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
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 he preparation, monitor and communicate status of regulatory submissions to appropriate departments.
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 1-4 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.Skill Requirements:
Project management skills
Degree in RA or Regulatory Affairs Certification a plus
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 U.S. 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
Some travel is required ~ 10%
Management, leadership and mentoring skills and experience
Required/ Preferred Education and Experience:
8+ years of regulatory experience in the Medical Device Industry
Experience with medical device regulatory submissions (510(k) or PMA)
Previous experience working with Regulatory Authorities relative to premarket and compliance activities.
Experience with medical device submissions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.
Internal Number: 002
About ZOLL Medical Corporation
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!