# CE-IVDR Regulatory Consultant

**Company:** [AccuScan Sciences](http://jobs.workable.com/companies/trHQ5NyGdsqyThXBeGhJQp.md)
**Location:** Milpitas, United States
**Workplace:** hybrid

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## 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.

## 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.