Regulatory Affairs Specialist

Essential Duties and Responsibilities

  • Assist in the preparation of regulatory submissions and filings, such as applications, amendments, supplements, annual reports, deficiency letter responses, Form 483 responses, warning letter responses, adverse experience reports, recall communications, license renewals, registrations, reports, correspondence, telecommunications, etc.  Gather, assemble, and pre  pare appropriate documents for submission.
  • Independently research regulatory issues and/or information as directed.  
  • Independently track and follow-up on Regulatory commitments to assure commitments are completed and maintained. 
  • Prepare documents, as directed, for internal use or submission to regulatory authorities.  
  • Support regulatory filing processes in collaboration with a multi-disciplinary professional support staff 
  • Independently monitor and improve tracking/control systems for regulatory documents
  • Other duties as assigned
Responsibility and Authority Affecting Quality
  • Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System.
  • Identify and record potential problems relating to the product, process and Quality System.
  • Initiate, recommend or provide solutions through designated channels.
  • Record and/or report all instances of customer feedback on product.
Position Requirements
  • Skills and abilities (required for the job)
    • Excellent communication skills
    • Excellent writing skills
    • Excellent skills in legal research
    • Strong organizational skills
    • Detail oriented
    • Ability to handle multiple tasks simultaneously
    • A team player
    • A self-starter
    • Experience in medical device post market surveillance preferred
  • Education, experience and training (required for the job)
    • Bachelor’s degree or equivalent combination of education and experience
    • 3 to 5 years of relevant experience, or equivalent
  • Working environment
    • Work Station Area:  Office
    • Special Factors in the Work Area:  None
    • The working environment is indoors and is seasonally heated and cooled with minimal noise levels.  
    • The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
    • The position requires the ability to communicate in person, telephonically and via email. 

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