Diagnostic Assay Scientist: IVDR Design & Validation

RAB Diagnostics

Oslo

Hybrid

NOK 900,000 - 1,200,000

Full time

46 hours ago

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Job summary

Rab Diagnostics in Oslo, Norway, is seeking a Scientist for Diagnostic Assay Development & Design Control. This full-time, hybrid role focuses on design control development of diagnostic assays under IVDR regulation.

The candidate will work across development, quality, regulatory and biopharma partners to advance precision diagnostics. Responsibilities include conducting analytical-performance studies, establishing risk-based design control processes, and contributing to IVDR performance

Qualifications

Experience with design control, assay validation and documentation in a regulated environment.
Experience with IVD or medical device development under IVDR/MDR.
Experience defining assay specifications, acceptance criteria and analytical-performance studies.
Structured, evidence-based troubleshooting and strong scientific communication in English.
High collaboration skills and ability to work with cross-functional teams.
Proficiency in data analysis and reporting of findings.

Responsibilities

Design and execute analytical-performance studies (sensitivity, specificity, precision, repeatability, reproducibility, robustness, lot comparability, stability).
Establish and run a practical, risk-based design control system: design inputs/outputs, verification, validation, traceability, design transfer.
Integrate risk management per ISO 14971 and contribute to IVDR performance evaluation (scientific validity, analytical and clinical performance).
Collaborate across development and clinical, quality, regulatory and biopharma partners.