Regulatory Manager - Mansfield, MA || Katalyst HLS

Regulatory Manager - Mansfield, MA - www.KatalystHLS.com The Regulatory Manager is responsible for the support of new product development and Regulatory Subject Matter Expert for the assigned projects and for applicable manufacturing sites, regarding design, development, validation, commercialization of products throughout the product life cycle. Prepare submissions (ie., Premarket Approvals: US Class III (PMA) and 510(k), CE marking Applications, Technical documentation, etc.) to obtain domestic filings, European regulatory approvals, and maintain existing approvals through periodic reporting, supplements/notices, Letters to File, renewals, change notifications, etc. https://www.indeedjobs.com/katalysthls/_hl/en_US?cpref=JXWAtnzf3XWjLOi4YeVNLsKhmt5T2XHWmcmo0mlELvA

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