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.  

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.