CE-IVDR Regulatory Consultant

AccuScan Sciences 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 and future kit-based products.

The consultant will provide strategic and hands-on regulatory expertise to support CE-IVDR compliance, technical documentation development, performance evaluation strategy, Notified Body interactions, 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 to establish a scalable regulatory pathway for CE-IVDR market entry.

Key Responsibilities

CE-IVDR Regulatory Strategy

• Lead development of AccuScan's CE-IVDR regulatory strategy for oncology molecular diagnostic products.

• Assess regulatory classification and applicable conformity assessment routes.

• Advise leadership 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

• Advise on analytical and clinical performance studies required for CE-IVDR submission.

• Review study protocols and evidence packages supporting intended use claims.

• Ensure alignment of clinical validation data with CE-IVDR expectations.

Notified Body & Regulatory Agency Interactions

• Support Notified Body selection and engagement strategy.

• Participate in regulatory meetings and audits.

• Prepare and coordinate deficiency responses and remediation plans.

• Serve as regulatory subject 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.

• Support qualification of 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.

Requirements

Required

• Bachelor's degree or higher in Regulatory Affairs, Biology, Molecular Biology, Life Sciences, or related field.

• 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

• Approximately 10–20 hours per week initially.

• Increased involvement during technical file preparation and submission phases.

• Flexible remote engagement.

• Occasional travel for partner, Notified Body, or project meetings may be required.

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.