Quality Assurance - Regulatory Affairs Specialist


Miami, FL

Industry: IT Consulting/Services


Less than 5 years

Posted 273 days ago

This job is no longer available.

We are looking for Quality Assurance - Regulatory Affairs Specialist for our client in ???????Miami, FL

Job Title: Quality Assurance - Regulatory Affairs Specialist

Job Location: Miami, FL

Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire

Job Description:

  • Experience Level (Years) 3-5

Primary Responsibilities:

  • Lead and execute complex regulatory projects - implementation of new regulatory requirements, etc
  • Assist in development of regulatory strategy
  • Investigate and evaluate regulatory history / background of class
  • Review change orders and assess regulatory impact of product changes on international regulaotry strategy and submissions
  • Support post-market regulatory compliance activities
  • Provide regulatory review of labeling, design changes, and specification changes
  • Work with RA teams and develop international strategies for product submissions
  • Other duties as assigned

Required Skills & Abilities:

  • Bachelor's degree in Engineering or related field
  • 4years of relevant work experience in a similar role in Medical Device domain
  • Knowledge of regulation of Medical Devices for US and Europe
  • Knowledge of upcoming regulatory changes
  • Knowledge of FDA requirements and guidelines
  • Knowledge of 21CFR820 regulatory requirements