Job Description
Own Risk Management File/RSL per ISO 14971 with full traceability to design and verification.
Lead cross-functional risk reviews; ensure risk controls are implemented, verified, and validated within DHF/Technical File.
Develop Regulatory Compliance Declarations (RCDs) for EU MDR/IVDR, FDA, UKCA aligned to IEC 60601, IEC 62304, IEC 62366-1, IEC 60601-1-2.
Manage standards compliance strategy, gap assessments, safety/EMC/software/usability testing, and audit NC closure.
Perform component & supplier compliance (COTS/SOUP, safety, EMC, biocompatibility, RoHS/REACH, cybersecurity); maintain CoC/CoA and approvals.
Author regulatory technical documentation (RMF, GSPR/ER mapping, labeling/IFU, clinical links) supporting CE/FDA approvals.
Support V&V, change control, and CAPA, assessing impact on risk, standards, testing, and regulatory filings.
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