Quality Systems and Regulatory Specialist

East Bay, (none selected) | Direct Hire

Post Date: 08/01/2016 Job ID: 1074
  • Understand and influence the company on requirements of Regulatory Agencies such as FDA, BSI and standards-setting organizations such as ISO, AAMI and ANSI.
  • Ensure labeling is consistent with product regulatory affairs approvals.
  • Manage legal marketing status of products globally.
  • Provide interpretation and guidance on regulatory affairs requirements and laws for new and existing products.
  • Write, review, document, and implement requirements into NDC procedures.

Essential Duties and Responsibilities include the following. (Other duties may be assigned):

  • Prepare and submit original registrations, amendments, supplements, variations, maintenance reports and other documents to regulatory agencies in line with local regulatory requirements including but not limited to Canada, Singapore, Taiwan, Indonesia, Russia, India, and Slovakia.
  • Assist in preparation of regulatory strategies and identification of regulatory requirements for submissions to insure the efficient approval and registration of products.
  • Provide regulatory affairs guidance to project teams.
  • Prepare and submit 510k’s and technical files to regulatory bodies as needed for CE mark approval, CE supplement approval and 510k approval.
  • In a QA role, and as part of QA department, support ISO13485/CMDCAS, FDA QSR and medical device directives compliance activities throughout organization including, but not limited to, CAPA system, supplier evaluation system, and internal audit system.

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