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Regulatory Affairs Engineer/Specialist

AMERICAN ORTHODONTICS • Sheboygan, WI, US • published 2026-10-14 02:23:50.242457

Description

Duties and Responsibilities * Support Engineering and Product Development teams to successfully complete and obtain product registrations * Determine the types of regulatory submissions or documentation required for projects with product design changes, manufacturing changes, or labeling changes * Advise project teams on subjects such as pre\-market regulatory requirements, export and labeling requirements, and/or clinical study requirements * Communicate with customers and regulatory agencies to support product registrations * Create, manage, and organize technical documentation in a document control system for domestic and international registrations * Respond to questions from regulatory agencies and prepare additional documentation as requested * Manage projects related to maintaining product registrations in domestic and international markets * Support product vigilance activities through review of customer complaints, reportable incident databases, and clinical literature * Identify relevant guidance documents, international standards, or consensus standards and ensure these are communicated through corporate policies and procedures * Write and/or update Quality Management Sy...

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