Regulatory Affairs Specialist II

Irvine, CALIFORNIA | 4 months
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Job Summary


$135,193 Average salary of similar jobs | Check Salary...

Job Description

  • Represent RA on project teams for new or modified in vitro diagnostic devices (IVD).
  • Create and revise technical files for compliance with CE Marking.
  • Support international product registrations: license updates and renewals in accordance with country specific requirements.
  • Ensure labeling changes are implemented and communicate these changes to the selling regions, as needed.
  • Manage RA Change Request Process and ensure these are tracked in a log and all files completed and are audit ready.
  • 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.
  • Support internal audits for MDSAP and IVD requirements.
  • Manage SAP product restrictions.
  • 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 to insure that they meet applicable U.S. FDA requirements.

  • Bachelor’s degree in biology, chemistry, medical technology or related field.
  • Advance degree and/or Regulatory Affairs Certification are a plus.
  • 2+ years' experience in domestic and international regulatory compliance Affairs or combination of education and experience in the IVD industry. 
  • Working knowledge of FDA and CE Mark requirements.
  • Internal audits skills with lead auditor training/professional certification is preferred.
  • Knowledge of product labeling requirements.
  • Knowledge of International product registrations.
  • Strong customer orientation and focus.
  • Able to work independently and with others.
  • Effective communication skills, both written and oral.
  • Strong documentation and organizational skills.
  • Excellent computer applications skills and able to perform basic statistical analysis.

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 7,800  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 healthcare 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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