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Regulatory consultant

Company: LiveMindz
Location: Yorba Linda
Posted on: June 26, 2019

Job Description:

Regulatory consultant Locations Yorba Linda, CA or Boston. JD Prepares regulatory submission for submission, including US 510K, European Union Technical File, and Health Canada submissions. Provide business level support for International Registrations. 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 internalcorporate 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 1-3 years related experience in the medical device, pharmaceutical, andor medical diagnostics industry, with a preference for experience in Regulatory Affairs. Bachelor of Science degree in engineering or a scientifictechnical discipline. Master of Science degree in engineering or a scientifictechnical discipline preferred. Certified Quality Manager or Regulatory Affairs Certification (RAC) preferred. Ability to fluently read, write, and speak in English is required.

Keywords: LiveMindz, San Diego , Regulatory consultant, Professions , Yorba Linda, California

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