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.