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Regulatory Specialist II
Ref No.: 18-08253
Location: Miami, Florida
Position Type:Scientific (T)
Start Date / End Date: 06/05/2018 to 12/17/2018
Our client, a leading medical devices company is looking for a Regulatory Specialist II. This is for an initial duration of 6 months and is located in Miami, FL
 
Description:
  • The Senior Regulatory Affairs Specialist integrates client’s regulatory strategies and programs to support new product development and commercial product maintenance.
  • As a regulatory process expert to development teams, the incumbent support global registrations and compliance activities; provides regulatory review of promotional material, experimental designs, data analysis and product labeling as related to registration and commercialization of medical devices; collaborates with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees to develop harmonized policies, procedures and work instructions for emerging regulatory topics
 
Educational Requirements:
  • Bachelor’s degree (or foreign equivalent) in Science, Regulatory Affairs, or Engineering plus 3 years of experience in the offered position.
 
Special skills requirements:
  • Experience implementing premarket regulatory strategy.
  • Experience writing and submitting premarket submissions to regulatory agencies.
  • Experience preparing submissions for FDA establishment registrations, Canadian site license renewals, US State licenses and USDA licenses.
  • Experience applying 21 CFR 801, 803, 806 and 820 regulations.
  • Experience communicating with regulatory agencies including FDA, Health Canada and EU regulatory agencies and responding to agency inquiries.
 
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.