Regulatory Affairs Specialist

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!

Primary Purpose:

Responsible for the implementation and administration of organization activities to support and ensure regulatory compliance.

Primary Functions:

• Understands and has working knowledge of FDA medical device regulations, European Medical Device Directives, and/or other global regulations

• Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory strategy plan around product development goals.

• Prepares US FDA submissions (eg. 501(k), IDE, PMA) as required and per applicable SOPs.

• Initiates and updates technical files/dossiers/registrations as required and per applicable SOPs

• Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards

• Implement submission templates

• Monitors and maintains regulatory files in good order

• Maintains current knowledge of device regulations, guidance and standards applicable to device product submissions. Analyzes the information and provides updates

•  Participates in department improvement activities. Makes recommendations for process improvements to improve efficiency and accuracy of device submissions and other procedures.

• Assist with device recall activities

• Participate as an auditor in internal audit activities

• Review, disposition and approve Engineering Change Requests

• Other duties as assigned

• Some travel is required ~10%

Competencies:

• Demonstrated working knowledge of scientific principles

• A Self-starter with the ability to work independently with minimal supervision and as part of a small team

• Very detailed oriented, well organized and driven to meet deadlines and program goals

• Strong verbal and written communication skills

• Good computer skills with knowledge of Microsoft Office

• Knowledge of FDA, European, Canadian and Japanese Regulatory Requirements

• Ability to Multitask and prioritize

• University Degree with 3 - 5+ years experience or a Master’s Degree in a Regulatory Affairs or related discipline.

Other Duties:
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.

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V. 

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990