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Regulatory Affairs Associate

Location: Chelmsford, MA

Resuscitation

Overview

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:

 

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

Responsibilities

  • Prepare 510 (k) and International product submissions.
  • Support international product registrations.
  • Prepare and maintain product Technical Files.
  • Manage organization's external document control.
  • Assist with device recall activities.
  • Interface with FDA and other International Regulatory Agencies personnel.
  • Identify corrective actions and process improvements.
  • Represent Regulatory Affairs in multi-discipline product development teams.
  • Ensure that all work activity is performed in accordance with established procedures and regulatory requirements.
  • Prepare and maintain various documentation required by the FDA.
  • Participate as an auditor in internal audit activities.
  • Participate as the Regulatory Affairs representative in Engineering Change Order review meetings.
  • Other duties as assigned.

Qualifications

  • Excellent oral and written communication skills.
  • Excellent organization skills.
  • Knowledge of FDA, European, Canadian and Japanese Regulatory Requirements.

Required/Preferred Education and Experience:

  • Four year college degree with 1-2 years related experience or a Master's Degree in a Regulatory Affairs or related discipline with 0-1 year related experience in a medical device regulatory capacity.

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.