Manage and provide regulatory guidance, support, and compliance for all regions. This function will be
the recognized expert, managing projects or processes, with responsibilities that include working with
cross-functional areas to identify, modify, or create necessary documentation to meet the global
regulatory requirements and implement regulatory strategy for different projects.
Required Qualifications
• Bachelor’s degree or Advanced Degree in Science or Health Related Field
• Minimum 3 years of experience in the medical devices sector and regulatory knowledge –
Mandatory
• Working knowledge of international laws, regulations, and guidance
• Experience with Class II/III medical devices
• familiarity with FDA requirements, the requirements of European Directive and Canadian
requirements
• Experience working with China APAC based sites – Advantage
• Experience working in a global company – Advantage
• Fluent in English, Excellent expression skills – written and verbal
