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EU CDx Regulatory Consultant
- Posted: 24/04/2023
- Salary: NA
- Location: Remote
- Job Type: Contract
The opportunity to join a multinational healthcare company within CDx regulatory division based remotely in the EU. You will work as a freelancer for 1+ year project supporting strategy development and provide advise for the CDx European Operations. You will be part of a global team, working on a non-oncology portfolio.
Candidate requirements:
Candidate requirements:
- Several year's experience working within regulatory affairs supporting CDx (companion diagnostics) and IVD portfolios.
- Experience conducting technical documentation submissions.
- Strong understanding of US FDA and EU MDR standards.
- Experience working on non-oncology product portfolios (desirable).
- Flexible for occasional travel to visit pharma partners (10%)
- Must be living in Europe.
Hannah Hughes
Team Lead/Senior Consultant