Company Description
OncoDNA, founded in 2012 and headquartered in Belgium, is a leading genomic and theranostic company focused on improving cancer treatment through precision medicine. OncoDNA offers a comprehensive portfolio, including NGS services, biomarker testing, data analysis software, and clinical decision support tools. We collaborate with healthcare professionals, researchers, and organizations to enhance treatment outcomes for cancer patients worldwide. For more information, visit www.oncodna.com.
Role Description
This role requires balancing deep regulatory knowledge with hands-on experience in NGS technology to navigate IVDR’s strengthened requirements for clinical evidence, risk management, and lifecycle monitoring.
This is a full-time on-site role located in Gosselies (BE)
Main responsabilities
Product Development
· Maintain or develop NGS products dedicated to the field of oncology from product design to validations.
· Ensure product development compliance with ISO13485, IVDR and other applicable standards and regulations.
Technical Documentation Management
* Develop and maintain product technical Files in compliance with ISO13485 and IVDR containing:
* Intended purpose and performance claims
* Design control documents
* Analytical/clinical performance evaluations
* Clinical evidence from literature reviews and post-market data
* Instructions for use and labels
Quality Management System (QMS)
* Maintain or develop procedures related to product development in compliance with the QMS of the company
* Participate to audits with Notified Bodies, customers or regulators.
Cross-Functional Collaboration
You acts as a central product knowledge reference, ensuring that technical product details are clearly documented, aligned with the QA system, and translated into understandable and usable information for Sales and distributors, while maintaining strong alignment across Product, IT, Sales and Marketing.
Qualifications
* Master’s or PhD in Molecular Biology, Biomedical Engineering, or related field
* At least 5 years of experience in a laboratory
* Strong understanding of NGS based diagnostics, with solid knowledge of the NGS market and liquid biopsy applications
* Expertise in ISO 13485, ISO 14971, and IVDR clinical evidence requirements
* Interest in the technical aspects of the OncoDNA Products as well as Genomic services proposed to the scientific community
Soft Skils
* You have knowledge of the complete NGS flow in the lab
* Experience working closely with IT, BioIT and scientific Teams
* Proven experience in a Product Owner, product Specialist or similar role in Life Sciences
* Ability to act as a bridge between customers, scientific teams, Bio IT, Sales and other teams
* Rigor, methodology,