Product Development Specialist

☞ OncoDNA

看过: 101

更新日: 27-11-2025

位置: Charleroi Hainaut

类别: 生产/工艺 市场/公关

行业: Biotechnology Research

水平: Mid-Senior level

工作类型: Full-time

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工作内容

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
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最后期限: 11-01-2026

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