Regulatory Affairs Specialist

Billerica, MA

Posted: 10/12/2018 Employment Type: Perm Industry: Life Sciences Job Number: 227652

Regulatory Filings to FDA


  • Assist with any regulatory findings including preparation of required documents, revision of documents to meet regulatory requirements, and compilation of final submissions
  • Maintenance of regulatory files

 

Annual Laser Report


  • Submit the Annual Laser Report to FDA each year
  • Maintain reports internally

 

Credentials


  • Ensure that Laser Safety Officer(s) maintain proper training and certification for their position
  • Ensure that Medical Director, Clinic Nurse(s), Clinical Educators and other healthcare providers maintain proper continuing education and certification to retain the credentials necessary for their positions

 

Records Retention


  • Ensure that all records are retained in compliance with guidelines from HIPAA, FDA and other governing bodies
  • Register each user facility with the FDA
  • Maintain each user facility by paying applicable user fees each year

 

Device Listing


  • Register each device with FDA
  • Maintain device listings by updating the status (active, inactive)

 

Letter to File


  • Maintain Letter to File for each device
  • Review LTF requests, including making any necessary changes to LTF draft

 

Operator’ s Manual


  • Maintain and manage the operator’ s manual for each device
  • Revise operator’ s manual as needed to meet regulatory or company requirements

 
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