5+ years of progressive experience in regulatory affairs.
Experience in regulatory affairs related to medical devices, including regulatory submissions and regulatory documentation.
Working knowledge of regulatory compliance requirements for medical devices and environmental regulations.
Proficiency in Microsoft Office Suite, including Word, Excel, Project, Visio, PowerPoint, and Outlook.
Strong problem-solving and analysis skills, including familiarity with statistical process control.
Technical capacity with sound decision-making, clear communication, and accurate reporting.
Strong interpersonal communication skills with the ability to collaborate across functions.
Solid organizational skills with the ability to manage multiple tasks and priorities.
Appropriate combination of education and experience in regulatory affairs.