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Regulatory Affairs Specialist

1 month ago

Fremont, United States Integration International Inc. Full time

Job Description:

  • Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Tasks include:
  • Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide.
  • Support the preparation of dossiers and submission packages for regulatory agencies, including IVDR Technical Dossiers for CE Mark approval.
  • Coordination with partner channel regulatory colleagues to obtain product approvals.
  • Organize, update, and maintain regulatory documentation in accordance with department and company procedures including maintaining logs and trackers.
  • Maintain positive and cooperative communications and collaboration with all levels of employees and partners
  • Request and track document legalization, apostille and requests for certificates from regulatory agencies.
  • Process changes orders for approval of documentation in electronic records management system
  • Perform other related duties and responsibilities, on occasion, as assigned.


Keys to Success:

  • A bachelor’s degree with a preference for majors in Science or Engineering is required.
  • Experience and excellent understanding of EU IVD regulation
  • Excellent verbal and written communication skills, and attention to detail.
  • Multitasks, prioritizes, and meets deadlines in a timely manner.
  • Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously
  • Strong verbal communication with ability to effectively communicate at multiple levels in the organization
  • Must be able to write clear, understandable technical documentation, i.e. regulatory documentation
  • Proficient in MS applications (Excel, Word, Outlook).
  • This position is on site at Fremont, California facility