The Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries. The Lead Regulatory Affairs Manager, International supports or leads the creation and execution of regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives. * Demonstrate continuous pursuit of global regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including IVDR, UK CA, FDA and Health Canada regulations and policies applying to In Vitro Diagnostic medical devices including, PMAs, 510(k)s, labeling and promotional materials, global registration, and technical writing.
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