EU IVDR Regulatory Lead for Oncology Molecular Diagnostics

AccuScan Sciences; Milpitas (CA); On-site; USD 140,000 - 210,000; Part time

Job summary

AccuScanSciences is seeking an experienced CE-IVDR Regulatory Consultant to lead and support European regulatory strategy for our oncology molecular diagnostics portfolio, including tumor-informed MRD assays.

The role provides strategic and hands-on regulatory expertise to support CE-IVDR compliance, technical documentation, performance evaluation strategies, Notified Body interactions, and cross-functional collaboration with product development, quality, manufacturing, and external CDMO

Qualifications

• Minimum 8 years of IVD regulatory experience.
• Direct experience leading CE-IVDR submissions.
• Strong understanding of EU IVDR (2017/746).
• Experience with Notified Bodies.

Responsibilities

• Lead development of CE-IVDR regulatory strategy for oncology molecular diagnostic products.
• Develop regulatory deliverables including Intended Use Statements, PEP, PER, risk management files, and labeling.
• Coordinate Notified Body interactions and regulatory meetings.
• Ensure traceability across design controls and technical documentation.
• Support CDMO selection and manufacturing transfer from regulatory perspective.

Skills

Regulatory strategy

Project management

Regulatory communication

Education

Bachelor's or higher in Regulatory Affairs or Life Sciences

Job description

AccuScanSciences is seeking an experienced CE-IVDR Regulatory Consultant to lead and support European regulatory strategy for our oncology molecular diagnostics portfolio, including tumor-informed MRD assays.

The role provides strategic and hands-on regulatory expertise to support CE-IVDR compliance, technical documentation, performance evaluation strategies, Notified Body interactions, and cross-functional collaboration with product development, quality, manufacturing, and external CDMO