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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Job ID 
2018-1181
Job Locations 
US-MA-Chelmsford
Category 
Quality, Regulatory Affairs, and Service
Type 
Full-Time/Regular

More information about this job

Overview

Responsible for the implementation and administration of organization activities to support and ensure regulatory compliance.  Reports to Regulatory Affairs Manager.

 

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 and other International Regulatory Agencies.
  • Participate as an auditor in internal audit activities.
  • Participate as the Regulatory Affairs representative in Engineering Change Order review meetings.
  • Other duties as assigned.

Skill Requirements:

 

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

 

Qualifications

  • Four year college degree with 4 plus years related experience or a Master’s Degree with 2 plus years 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