CE-IVDR Regulatory Consultant
Employment type
Full-time
Work setting
On-site
Location
Milpitas, CA
Schedule
Day shift
Posted
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Job overview
The CE-IVDR Regulatory Consultant role is described as hybrid remote, with the listing in Milpitas, CA. Compensation is not specified. The consultant supports European regulatory strategy for AccuScan Sciences’ oncology molecular diagnostics portfolio, including tumor-informed MRD assays and future kit-based products.
What you'll do
- Lead CE-IVDR regulatory strategy and assess product classification and conformity assessment routes. Develop and review technical documentation and performance evaluation materials
- advise on clinical and analytical evidence
- support Notified Body selection, meetings, audits, and deficiency responses
- partner on IVDR-compliant design controls and quality documentation
- and review regulatory aspects of kit development, manufacturing transfer, and CDMO qualification.
What we're looking for
- Skills & competencies
- ce-ivdr regulatory consultantmilpitas caaccuscan sciencesregulatory affairseu ivdroncology diagnosticsmolecular diagnosticsmrd assaystechnical documentationnotified bodiesquality systemshybrid remote
- Work arrangement
- Weekend coverage required
Why this role
The posting estimates an initial commitment of approximately 10–20 hours per week, with increased involvement during technical-file preparation and submission phases; occasional travel may be required.
About the employer
AccuScan Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.
Additional details
- Industry sector
- 54
- Industry
- Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Occupation code
- 13-1041.00
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Listing ID: 70d42565-85a0-4aea-b476-05ad84cd7fd6