Scientist, Diagnostic Assay Development & Design Control

RAB Diagnostics; Oslo; Hybrid; NOK 900,000 - 1,200,000; Full time

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.

Skills

Design controls

Assay validation

IVDR/MDR experience

Assay specifications

Data analysis

Scientific communication

Collaboration

Education

MSc/PhD in pathology/biochemistry/biomedical science

Job description

Rab Diagnostics support precision medicine, specializing in novel biomarkers for Antibody-Drug Conjugates (ADCs) and Radioligand Therapy (RLT). Using our proprietary RabCANCER platform and expertise in intracellular drug trafficking, the company works with biopharmaceutical partners to advance precise and effective cancer therapies for patients.

Role Description

The Scientist, Diagnostic Assay Development & Design Control is a full-time, hybrid role based in Oslo, Norway. This role involves design control development of diagnostic assays under IVD regulation (IVDR).

What you'll do

• 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

Key Qualifications

• MSc or PhD in pathology, pharmacy, molecular biology, biochemistry, biomedical science or a related field
• 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 Collaboratory skills
• Proficiency in data analysis and research, including statistical evaluation, interpretation of complex datasets, and clear reporting of findings.

Nice to have

• Experience developing, optimizing and validating tissue-based biomarker assays or other diagnostic assays used in clinical diagnosis of patients
• Experience in digital pathology and image-analysis validation
• Knowlege on cancer precision medicine and biomarker development
• Previous record of design controls under ISO 13485
• Working knowledge of IVDR, ISO 13485/14971 and relevant CLSI guidelines

What we offer

• A central role in bringing our first CE-IVD products to market, broad responsibility from early feasibility through CE marking, short decision paths and real impact, at the intersection of ADC biology, pathology and precision oncology.
• Rab Diagnostics is an equal-opportunity employer.

We plan to close the job by October 1st at the latest.