RAC Consultant

RAC Consultant

02 Mar 2024
California, Irvine, 92602 Irvine USA

RAC Consultant

Vacancy expired!

Hi,
Hope you are doing well.

This is Sid from E-Solutions Inc., we have an urgent positions with our direct client, kindly send me your updated resume at if you are suitable for following

Role: RAC Consultant
Location: Irvine, CA
Duration: Long Term Contract

Job Description:-
Prepares regulatory submission for submission, including US 510K, European Union Technical File, and Health Canada submissions. Provide business level support for International Registrations.
Exp in MDR requirement and submissions
Review labeling for Regulatory compliance.
Maintains awareness of global regulatory legislation and its impact on business and product development programs.
Provide expertise and guidance to project teams in interpreting US and foreign governmental regulations, agency guidelines, and internal/corporate policies to ensure compliance is maintained and results are
achieved.
Work in close collaboration and partner with other departments and functions, including manufacturing, Quality and Regulatory, Supply Chain, Research & Development, and Clinical to optimize overall
operational efficiency and effectiveness.
Support external regulatory audits and inspections.
Provide regulatory input on sourcing and supply chain activities.
Support Regulatory compliance activities.
Requirements:
This position requires 5 years related experience in the medical device, pharmaceutical, and/or medical diagnostics industry, with a preference for experience in Regulatory Affairs.
Bachelor of Science degree in engineering or a scientific/technical discipline.
Master of Science degree in engineering or a scientific/technical discipline preferred.
Certified Quality Manager or Regulatory Affairs Certification (RAC) preferred.
Ability to fluently read, write, and speak in English is required.

Thanks & Regards,
Siddharth Chaudhary (Sid)
P:+1


Job Details

  • ID
    JC10487984
  • State
  • City
  • Job type
    Contract
  • Salary
    BASED ON EXPERIENCE
  • Hiring Company
    E-Solutions, Inc.
  • Date
    2021-03-01
  • Deadline
    2021-04-30
  • Category

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