Regulatory Affairs

Title:  Regulatory Affairs
Location:  Alpharetta, GA
Duration: 6+ months

Job Description:

  • Seeking a candidate who has quality/regulatory experience with 510K, Technical Files and STED.
  • At least 1 yr. regulatory affairs experience. 
  • Experience writing STED or technical files preferred; engineering background; tech writing exp.; revising docs; prepare submissions/dossiers.
  • Support regulatory compliance throughout the organization by performing the required activities that assure compliance with domestic and international regulations. 
  • Help refine and maintain systems for organizing and retrieving regulatory related information.
 
Responsibilities (fundamental job duties):

  • Maintain regulatory affairs files (e.g. scan, print, file)
  • Research, renew and obtain State Licensing where needed for the I-Flow facility.
  • Support and participate in audits performed by internal and external (e.g., FDA, Notified Body, etc) representatives.
  • Support the implementation of regulatory activities throughout the I-Flow facility.
  • Assist in preparation and execution of Field Action activities.
  • Provide regulatory support for International Registrations, DMRs, Technical files, Design Dossiers, etc.
  • Support MDR Analyst with Medical Device Reporting (MDRs) and Medical Vigilance Reporting (MDVs).

Want to apply later?

Type your email address below to receive a reminder

Apply to Job

ErrorRequired field
ErrorRequired field
ErrorRequired field
Error
Error
insert_drive_file
insert_drive_file