of personal information from individuals who live in the European Union (EU)....
safety and recommended actions. Regulatory Compliance: Ensure all activities comply with FDA, EU MDR, ISO 13485... regulations and standards (e.g., FDA 21 CFR 820, EU MDR, ISO 14971). Experience with CAPA processes and root cause analysis...
Islands, EU, other) Overseeing and working closely with corporate partners (i.e. risk, law division, corporate compliance...
in eCTD publishing systems. Strong knowledge of FDA/EU/ICH guidelines related to regulatory submissions. Additional Skills...
and translating business requirements into technical specifications. - Experience in designing Oracle Financials in EU countries...
with both U.S. and EU teams. What You’ll Do: Serve as CrowdStrike’s legal leader for information governance. In this role...
knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines. Experience collaborating...
Preferred Qualifications Experience with ComplianceWire, Global TrackWise, and/or OneVault Experience working with EU MDR...
knowledge of major AML regulatory frameworks (e.g., BSA/AML, EU AML Directives, MAS guidelines) and their practical application...
and technical realities. Familiarity with global digital safety regulations (e.g. EU DSA, UK Online Safety Act, etc.) Proven...