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Associate Regulatory Affairs Specialist III
Ref No.: 19-11851
Location: Alpharetta, Georgia
Our client, a leading medical device company is looking for a Associate Regulatory Affairs Specialist III. This is for an initial duration of 3 months and is located in Alpharetta, GA
Description/Comment:
  • 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).
Hours: 8:00am to 5:00pm
Additional Job Details:
  • seeking a candidate who has quality/regulatory experience with 510K, Technical Files and STED;
The requirements are:
  • At least 1 yr. regulatory affairs experience.
  • Experience writing STED or technical files preferred; engineering background; tech writing exp.; revising docs; prepare submissions/dossiers ; we would like experience with Latin America submissions, but not required.
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.