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Associate Regulatory Affairs Specialist III
Ref No.: 20-00049
Location: Alpharetta, Georgia
Our client, a leading fortune company is looking for a Associate Regulatory Affairs Specialist. This is for an initial duration of 6 months and is located in Alpharetta, GA

Job Details:
  • Seeking a candidate who has regulatory experience with 510K, Technical Files and STED.
 The minimum requirements are:
  • At least 1 yr. regulatory affairs experience.
  • Experience writing STED or technical files preferred.
  • Knowledge of EU MDR preferred.
 Description:
  • 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.
  • Support and participate in audits performed by internal and external (e.g., FDA, Notified Body, etc) representatives.
  • Support the implementation of regulatory activities
  • 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).
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com / neha.T@sunrisesys.com.  Thank You.