JOB DESCRIPTION
Contract Type
Candidate (Freelancer)
Company Type
CRO / CDMO
Company Size
Small 100 – 1000
Requested Expertise
Regulatory Affairs / Clinical study / Clinical development / Medical Writing / Scientific communications
Profile Required
## Required expertise
– Minimum Master’s degree in a scientific discipline; PhD is a plus.
– At least 5 years of experience in the diagnostics / IVD sector.
– Proven hands-on experience contributing to or leading IVD regulatory submissions in Europe.
– Strong knowledge of clinical and scientific documentation for IVDR technical files.
– Experience with molecular diagnostics is preferred.
– Familiarity with US IVD regulatory requirements and FDA interactions is a strong plus.
– Excellent written English. French-speaking candidates are preferred, but this is not mandatory.
## Seniority
Mid-to-senior level, with demonstrated experience delivering IVD submission documentation.
Project Description
We are looking for a part-time IVD Clinical Scientist to support an early-stage in-vitro diagnostics development project.
The expert will support the preparation of clinical and scientific documentation required for IVD regulatory submissions, primarily in Europe under IVDR, with potential interaction with the FDA and US requirements.
The scope is focused on clinical documentation and regulatory-support activities; an R&D team is already in place.
## Scope of work
– Prepare and review clinical and scientific documentation for IVD technical files.
– Conduct literature reviews and develop state-of-the-art documentation.
– Support the clinical evidence strategy and performance-study documentation required under IVDR.
– Contribute to technical documentation for submissions to notified bodies and regulatory agencies.
– Support interactions and preparation of documentation for regulatory authorities, including the FDA where relevant.
– Ideally, help identify and approach hospital partners for sample collection and performance-study collaborations.
## Engagement model
Embedded resource, working alongside the internal regulatory lead and project team.
## Timing and availability
– **Start:** ASAP
– **Commitment:** approximately 3 days per week
– **Initial duration:** Q4 2026
– Potential extension depending on project and client needs.
## Location
Full Remote is possible. Initial on-site presence in the Marseille/Aix (France) area would be appreciated to support project onboarding.
Applications expected by September 30th 2026 at the latest.
Therapeutic Area
All
Language
English,French
Hard Skills
Soft Skills
Seniority Level
Experience 5 – 10 years,Experience > 10 years
Starting Date
2026-10-01
Project Duration
Initial 3 months (potential extension depending on project and client needs)
FTE / nb of days per week
3
Project Location
Marseille, France
Remote Flexibility
Yes
Travel Expected
No
Approximative Budget
Any other information of interest
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