CE-IVDR Regulatory Consultant

AccuScan Sciences; Milpitas (CA); Remote; USD 130,000 - 180,000; Full time

Job summary

AccuScanSciences seeks an experienced CE-IVDR Regulatory Consultant to lead and support European regulatory strategy for oncology molecular diagnostics, including tumor-informed MRD assays and future kit products.

You will provide strategic and hands-on regulatory expertise to achieve CE-IVDR compliance, technical documentation, performance evaluation strategy, and Notified Body interactions while enabling Europe market entry.

Qualifications

• Minimum 8 years of IVD regulatory experience.
• Direct experience leading CE-IVDR submissions.
• Strong understanding of EU IVDR (2017/746).
• Experience preparing CE-IVDR technical files and performance evaluation documentation.
• Experience working with Notified Bodies.
• Experience supporting oncology molecular diagnostics, NGS assays, liquid biopsy, or precision oncology products.

Responsibilities

• Lead CE-IVDR regulatory strategy for oncology molecular diagnostics products.
• Advise leadership on regulatory risks, timelines, and commercialization requirements.
• Develop and review CE-IVDR technical documentation (TDF, PEP, PER, labeling).
• Coordinate Notified Body interactions and submission activities.
• Ensure design controls and QA alignment across development and manufacturing.
• Support CDMO partners and manufacturing transfer activities.

Skills

Regulatory strategy

Regulatory submissions

Project management

Cross-functional collaboration

Regulatory affairs

Education

Bachelor’s or higher in Regulatory Affairs / Life Sciences

Job description

AccuScanSciences is seeking an experiencedCE-IVDR Regulatory Consultantto lead and support European regulatory strategy for our oncology molecular diagnostics portfolio, including tumor-informed MRD assays and future kit-based products.

The consultant will provide strategic and hands-on regulatoryexpertiseto support CE-IVDR compliance, technical documentation development, performance evaluation strategy,Notified Bodyinteractions, and commercialization of oncology molecular diagnostic products in Europe. The role will work cross-functionally with product development, clinical affairs, quality, manufacturing, bioinformatics, and external CDMO partners toestablisha scalable regulatory pathway for CE-IVDR market entry.

Key Responsibilities

CE-IVDR Regulatory Strategy

• Lead development ofAccuScan'sCE-IVDR regulatory strategy for oncology molecular diagnostic products.
• Assess regulatory classification and applicable conformity assessment routes.
• Adviseleadership on regulatory risks, timelines, and commercialization requirements.
• Interpret and apply EU IVDR (Regulation (EU) 2017/746) requirements.

Technical Documentation & Technical File Development

• Lead preparation and review of CE-IVDR technical documentation.
• Develop regulatory deliverables including:
  • Intended Use Statements
  • Performance Evaluation Plans (PEP)
  • Performance Evaluation Reports (PER)
  • Risk Management Files
  • Clinical Performance Documentation
  • Analytical Performance Documentation
  • Labeling and IFU content
  • Post-Market Surveillance Plans
• Ensure traceability across design controls and technical documentation.

Clinical & Performance Evidence

• Adviseonanalytical and clinical performance studiesrequiredfor CE-IVDR submission.
• Review study protocols andevidencepackages supporting intended use claims.
• Ensure alignment of clinical validation data with CE-IVDR expectations.

Notified Body & Regulatory Agency Interactions

• Support Notified Bodyselectionand engagement strategy.
• Participate in regulatory meetings and audits.
• Prepare and coordinate deficiency responses and remediation plans.
• Serve asregulatorysubject matter expert during submission activities.

Quality System Integration

• Partner with QA and product development teams to establish IVDR-compliant design controls.
• Ensure alignment between product development, manufacturing, and regulatory requirements.
• Review SOPs, DHF, risk management, and validation documentation.
• Provide guidance on post-market surveillance and vigilance activities.

CDMO & Manufacturing Support

• Review regulatory aspects of kit development and manufacturing transfer activities.
• Supportqualificationof CE-IVDR-capable CDMO partners.
• Ensure regulatory requirements are incorporated into manufacturing and quality agreements.
• Review stability, QC, and release testing strategies supporting CE-IVDR submissions.

Required

• Bachelor's degree or higher in Regulatory Affairs, Biology, Molecular Biology, Life Sciences, or relatedfield.
• Minimum 8 years of IVD regulatory experience.
• Direct experience leading CE-IVDR submissions.
• Strong understanding of EU IVDR (2017/746).
• Experience preparing CE-IVDR technical files and performance evaluation documentation.
• Experience working with Notified Bodies.
• Experience supporting oncology molecular diagnostics, NGS assays, liquid biopsy, or precision oncology products.
• Strong project management and communication skills.

Preferred

• RAC certification and/or advanced regulatory credentials.
• Experience with oncology MRD, ctDNA, liquid biopsy, or companion diagnostics.
• Experience with distributed kit products and CDMO manufacturing models.
• Knowledge of ISO 13485 and European quality system requirements.
• Prior experience supporting US FDA and global regulatory submissions.

Estimated Commitment

• Approximately10–20 hours per weekinitially.
• Increased involvement during technical file preparation and submission phases.
• Flexible remote engagement.
• Occasional travel forpartner,Notified Body, or project meetings may berequired.

Preferred Candidate Profile

The ideal candidate has successfully led CE-IVDR submissions for oncology molecular diagnostics, liquid biopsy, NGS, or companion diagnostic products and has firsthand experience interacting with Notified Bodies. Experience bringing a novel molecular assay from development through CE-IVDR commercialization would be highly desirable.