knowledge of design controls and regulatory requirements (US, EU, Japan, China). Proficiency in ICH-GCP/ISO 14155 and clinical...
Part 820/211, EU MDR and other applicable regulatory standards. This role manages document control transactions, site...
Duties Preparation of new and updated Core Data Sheets, EU and US Documentation: Independently manages, prepares..., draft US packaging components, EU SmPC, EU PIL, CCDS, annotated CCDS). Leads processes and associated systems to ensure...
-functional remediation plans. Monitor global regulatory trends (e.g., EU AI Act, U.S. federal/state rules, other market-based... expertise in enterprise data management, regulatory frameworks (GDPR, CCPA, EU AI Act), model risk, and AI governance. Track...
with cGMPs, EU, CFR and the USP Demonstrates good attention to detail and accuracy Good organizational skills and ability...
or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.... Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory...
, IEC 62304 and EU MDR as well as corporate procedures and requirements. Support cross-functional teams in the... regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971. Skilled in developing...
, Philippines, UK, India, Netherlands, and the EU. IntelliPro, a global leader connecting individuals with rewarding employment...
across cultures and geographies including partnering with statistical programming staff in AP and EU regions and offshore programming...
techniques. Ø Certification or Knowledge of Current Good Manufacturing Practice, FDA 21 CFR Part 11, and EMA EU GMP Annex 11...