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Quality Assurance/Regulatory Affairs Coordinator II

Location: Chelmsford, MA

Resuscitation

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:

This individual will support ZOLL's complaint handling and Regulatory reporting process. Responsible for regulatory decision making and reporting as a function of the complaint handling process. Works under immediate supervision using specific tasks and procedures. Reports to RA Supervisor and/or Quality Assurance Manager.

Essential Functions:

  • Review Service Request and/or Customer Call Reports (CCR) to determine if it qualifies as a complaint.
  • Evaluate all complaints to determine if the complaint qualifies as an event which is required to be reportable to a Regulatory Agency.
  • Prepare and maintain regulatory documentation in accordance with ZOLL procedures and within Regulatory compliance.
  • Coordinate and maintain closed service request system.
  • Communicate and correspond with customers.

Skill Requirements:

  • Have basic computer skills in a MS Windows environment.
  • Versatile
  • Organizing skills
  • Have above average Oral and Writing communication skills.
  • Ability to communicate and work effectively within a multi-disciplined organization.
  • Knowledge of FDA Regulations or experience in a medical device environment.
  • Knowledge of medical Device Reporting including international regulations.

Required/Preferred Education and Experience:

  • Requires 2-year degree or equivalent work experience and 4 plus years related experience.
  • Preferred certification in the Regulatory related to complaint handling

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