CE-IVDR Regulatory Consultant

Key Responsibilities: CE-IVDR Regulatory Strategy Lead development ofAccuScan'sCE-IVDR regulatory strategy for oncology molecular diagnostic products. Assess regulatory classification and applicable conformity assessment routes. Adviseleadership 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 PlansEnsure traceability across design controls and technical documentation. Clinical & Performance Evidence Adviseonanalytical and clinical performance studiesrequiredfor CE-IVDR submission. Review study protocols andevidencepackages supporting intended use claims. Ensure alignment of clinical validation data with CE-IVDR expectations. Notified Body & Regulatory Agency Interactions Support Notified Bodyselectionand engagement strategy. Participate in regulatory meetings and audits. Prepare and coordinate deficiency responses and remediation plans. Serve asregulatorysubject 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. Supportqualificationof 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 relatedfield. 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. PreferredRAC 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 Approximately10–20 hours per weekinitially. Increased involvement during technical file preparation and submission phases. Flexible remote engagement. Occasional travel forpartner, Notified Body, or project meetings may berequired. 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.