A current, up-to-date resume
Bachelor's degree in Biology, Chemistry, Medical Technology, or a related scientific discipline
5+ years of experience in domestic and international regulatory affairs or regulatory compliance
Extensive knowledge of global regulatory requirements, including FDA, NPMA, and IVDR regulations
Strong understanding of product labeling requirements and international product registration processes
Strong technical and regulatory writing skills
Experience using quality management systems and SAP applications
Ability to perform basic statistical analysis
Ability to meet compliance requirements
Must be eligible and provide proof of eligibility to work in the US