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Regulatory Affairs Coordinator

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:

 

Provide information and regulatory support to international RA team members for Product Registration, renewal and launches. To provide support and needed information for all products across client subsidiaries so regions can file products with data necessary for submission.

 

Responsibilities

  • Provide advanced administrative support to a department or function, filing of documentation, etc. 
  • Produce reports for managers utilizing Microsoft Application i.e., excel and/or presentation programs. 
  • Exercise discretion and independent judgment, analyze complex information requests and determine the correct course of action. Special projects/requests as required. 
  • Perform all routine assignments with minimal to no supervision. Receives general instructions on new work that is generally reviewed upon completion. 
  • Provide regulatory support for Health Authority submissions including but not limited to proofreading documentation, importing document in the document management system, bookmarking and linking pdf documents, etc. 
  • Liaison between cross-functional teams to support International requests and needs. 
  • Coordinates and prepares materials and presentations when needed. 
  • Knowledgeable on all corporate and functional policies and procedures. 
  • Understand all company practices and interfaces with management at all levels. 
  • Assist with cleanup and improvement of department organization systems. 
  • Develop documents with specialized formatting. 
  • Assist with scanning documents needed for use to support registrations. 
  • Assist with preparation of product dossiers. 
  • Flex position to assist with workload overflow and during team member absences. 
  • Help with data entry and labeling review. 
  • Request of CFS/GMP documents as needed. 
  • Authentication of CFS/GMP and other documents as needed. 
  • Preparing and coordinating product requisitions.
  • Other duties as assigned.

Qualifications

  • 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 
  • Driven to meet deadlines and program goals 
  • Strong verbal and written communication skills 
  • Excellent attention to detail and accuracy, including strong organizational skills are essential. 
  • Proactive and continual improvement mindset. 
  • Ability to handle multiple projects and track large amounts of dynamic data. 
  • Ability to research, read, understand and summarize technical data. 
  • Relevant computer knowledge and experience (Microsoft Suite, Google Suite). 
  • Fluent in both written and spoken English, with proficient written and oral communication skills.

Required/ Preferred Education and Experience: 

 

  • Minimum of two-year college degree with 0-2 years related experience in supporting role or coordinating role.

 

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.

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