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:
- Performance Evaluation Plans (PEP)
- Performance Evaluation Reports (PER)
- Clinical Performance Documentation
- Analytical Performance Documentation
- 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.