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RA Spec III

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RA Spec III

  • 2020-13156
  • Irvine, CA, United States
  • Provide regulatory support for the Exact Diagnostics (EDX) molecular controls and standards.
  • Support for EDX international product registrations: license updates and renewals in accordance with country specific requirements.
  • Represent RA on project teams for new or modified in vitro diagnostic devices (IVD).
  • Support implementation of the IVD Regulation for EDX products.
  • Create and revise technical files for compliance with CE Marking.
  • Ensure labeling changes are implemented and communicate these changes to the selling regions, as needed.
  • Support Field Action activities and ensure all documentation is audit ready
  • Participate in assessment of incidents for adverse event reporting. Prepare and submit U.S. FDA adverse event reports MDRs required.
  • Participate in review and implementation of new and/or revised external regulatory standards.
  • Participate in review and approval of marketing advertisements, promotional brochures, sales literature, booth handouts, web site product claims and product related press releases for EDX products to insure that they meet applicable U.S. FDA requirements.
  • Position requires future travel between California and Texas facilities. Up to 30% travel is required.

Responsibilities

  • Knowledge of ISO 17511 and metrological traceability of values assigned to calibrators and control materials is a plus.
  • Working knowledge of FDA, MDSAP, and CE marking requirements for IVD products is required.
  • Able to work independently and with others.
  • Excellent computer applications skills and able to perform basic statistical analysis
  • Strong critical thinking and problem solving skills
  • Strong customer orientation and focus
  • Effective communication skills, both written and oral
  • Strong documentation and organizational skills
  • Strong tact and negotiation skills

Qualifications

  • Requires a Bachelor Degree in Molecular Biology, Chemistry, Medical Technology or related field, advanced degree and/or Regulatory Affairs certification are preferred.
  • Five or more years of experience in regulatory affairs, clinical laboratory molecular testing environment and/or R&D and manufacturing within the IVD industry.

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000  employees and a global network of operations serving our customers, we help people live longer, healthier lives.

Bio-Rad was founded over six decades ago and has continued to provide the health-care industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

 

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To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

 

 

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