AccuScan Sciences→
CE-IVDR Regulatory Consultant at AccuScan Sciences in Milpitas, CA
Skills
Job Description
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.
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.