of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21CFRPart11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯
of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21CFRPart11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯
and standards for all applicable markets, including but not limited to: Hazardous Chemicals: UK & EU REACH, RoHS, California Proposition 65, AB1200 Food Contact Materials: EU 10/2011, FDA 21CFR 175-178 Electrical & Electronic Products: Low Voltage Directive (2014/35/EU), EMC Directive (2014/30/EU), Battery Directive (2006/66/EC More ❯