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:
* RUO→IVDR transition for reagents/controls
* IVDR-certified analysis software validation
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.
Key responsibilities
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
* Risk management reports (ISO 14971)
* Design control documents
* Analytical/clinical performance evaluations
* Clinical evidence from literature reviews and post-market data
* Instructions for use and labels
* Implement Unique Device Identification (UDI) systems for product traceability
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
* Work with other R&D members to make sure design control requirements are respected.
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
* Master’s or PhD in Molecular Biology, Biomedical Engineering, or related field
* 5+ years experience with IVD development under IVDD/IVDR67
* Demonstrated success in bringing Class C IVDs to EU market36
* Expertise in ISO 13485, ISO 14971, and IVDR clinical evidence requirements
Interested to join us ? please send you CV and letter to jobs@oncodna.com
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