Product Development Specialist

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