Job Details

ID #12215615
State California
City Irvine
Job type Contract
Salary USD TBD TBD
Source Denken Solutions
Showed 2021-04-14
Date 2021-04-14
Deadline 2021-06-13
Category Manufacturing
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RA(Regulatory Affairs)Consultant

California, Irvine, 92602 Irvine USA

Vacancy expired!

Currently, we are looking for talented resources for one of our listed clients. If interested please reply to me with your updated resume or feel free to reach out to me for more details on

949-208-7626.

Title: RA (Regulatory Affairs) Consultant

Location: Irvine, CA

Duration: Long term

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 the 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 of 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.
  • The Ability to fluently read, write, and speak in English is required.

Vacancy expired!

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