Senior AI SaMD Regulatory Strategist

ChipSoft

Location

Amsterdam, Netherlands
Published

27.09.2026
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Role description

ChipSoft ontwikkelt medische software ter ondersteuning van zorgprofessionals. Als Regulatory Affairs Specialist AI & SaMD levert u input voor intended purpose, classificatie en regulatory strategy voor AI-toepassingen in SaMD.

U werkt nauw samen met AI-teams, productmanagement en ontwikkelaars en vertaalt regelgeving naar concrete ontwerpkeuzes, tests en markttoegang. Ervaring met MDR/Ai Act en audits is gewenst; hybride werken mogelijk.

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Senior AI SaMD Regulatory Strategist

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