Back to job search

Regulatory Scientist IVDR

Oxford Global Resources offers a unique and excellent opportunity to work as a R&D Test Method Validation Scientist delivering services to a global IVDR supporting their activity across different departments such as Regulatory Affairs and R&D. This is initially an interim project 7-8 months duration which may mean an exciting professional career take off.

Job Description

The R&D Test Method Validation Scientist is responsible for the management of testing, results, and documentation to demonstrate assay performance of assays related to IVDR new guidance. Under the supervision of the Regulatory Projects Director, he/she is responsible to participate and support IVDR related projects and CFT teams to prepare technical files to be presented to the notified bodies, and provide evidence and rationale to the notified body queries, following strict quality rules.

Responsibilities

  • Be up to date of the relevant scientific, quality, and regulations related to new IVDR guidance.
  • Assist Regulatory Affairs in all task related to IVDR submissions.
  • Coordinate the R&D activities needed to support the preparation of technical file according to priorities and deadlines of submission.
  • Lead specific project meetings to analyze and discuss results generated by R&D department and redirects questions, if necessary.
  • Prepare or supervise regulatory reports like PER, APR, CPR, PEP, LoS, and T&A.
  • Execute all test method validation studies requested by IVDR teams in close collaboration with R&D teams involved. Write study POP protocols and reports and prepare presentations.
  • Knowledge support to other R&D teams in the execution of their assigned test method validation projects related IVDR.
  • Assure that projects under his/her responsibility are following internal procedures, are adapted to the quality system, and that all information is properly registered and maintained in the corresponding design history file.
  • Provide technical support to Quality Assurance, Quality Control, Manufacturing, and Technical Support.
  • Contribute to company innovation in the corresponding areas of responsibility.
  • Contribute to the preservation and dissemination of knowledge throughout the company.


Requirements

  • At least 1-year experience.
  • Demonstrated experience on new IVDR guidance and other and regulatory guidelines.
  • Risk management and setup specifications experience.
  • Knowledge immunoassay development.
  • Proficiency in the use of office automation software (Word, Excel, Powerpoint, SAP, etc.).
  • Fluency in Spanish and English.