Sophia Genetics SA
IVDR Regulatory Expert for Diagnostics/NGS (Hybrid)
Sophia Genetics SA, Boston, Massachusetts, us, 02298
A leading diagnostic solutions company is seeking an IVDR Expert to drive regulatory strategies and submissions within their Regulatory Affairs team. This role is pivotal in transitioning products from IVDD to IVDR, requiring at least 5 years of experience in regulatory affairs and a strong track record of successful submissions. The position allows for hybrid working, with benefits including comprehensive medical coverage and generous PTO. Candidates must be fluent in English, and applications should be submitted in that language.
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