OncoDNA is a genomic and theranostic company specializing in precision medicine for the treatment of cancer and genetic diseases. The company provides clinical guidance for treatment and monitoring of late-stage cancer patients, supports research, and drug development. OncoDNA offers a unique portfolio of NGS services, biomarker testing, data interpretation software, and clinical decision support tools.
With a global presence, the company is headquartered in Belgium and has entities in Spain, France.
We are looking to a Product Development Specialist with experience with NGS workflow components requiring IVDR compliance:
This role requires balancing deep regulatory knowledge with hands-on experience in NGS technology to navigate IVDRs strengthened requirements for clinical evidence, risk management, and lifecycle monitoring.
Key responsibilities
Product Development
Technical Documentation Management
Quality Management System (QMS)
Cross-Functional Collaboration
Partner with bioinformatics teams to help develop IVDR-compliant data analysis pipelines[Be specific when describing each of the responsibilities. Use gender-neutral, inclusive language.]
Example: Determine and develop user requirements for systems in production, to ensure maximum usability
Qualifications