Regulatory Affairs Engineer/Specialist

Support Engineering and Product Development teams to successfully complete and obtain product registrations by determining required submissions for design, manufacturing, or labeling changes. Advise project teams on pre-market, export, labeling, and clinical study requirements while communicating with customers and regulatory agencies. Create, manage, and organize technical documentation in a document control system for domestic and international registrations, responding to agency questions and preparing additional documentation as requested. Manage projects maintaining product registrations in multiple markets and support vigilance activities through review of customer complaints, incident databases, and clinical literature. Write and update Quality Management System procedures, standard operating procedures, and work instructions to align with domestic or international laws, guidelines, or standards. Maintain current knowledge base of relevant regulations and participate in internal and external audits. This position is 100% in-office in Sheboygan, WI.