Quality and Regulatory Compliance Specialist

Description

Since 1975, Computype has been a leading provider of track and trace solutions for critical applications in both industrial and healthcare markets. Over our history, innovation and striving to solve customer challenges have been at our core. Today, we offer a wide range of track and trace solutions, automation, and outsourced services to help our customers reduce labor, drive efficiency, and improve their workflows.

With a continued focus on future technologies, we are leading the way with new solutions, applications and opening doors of automated intelligence, enabling better communication and data management, tailored for specific customer applications.

This role is based at our headquarters in Saint Paul, MN.

The Quality & Regulatory Compliance Specialist is responsible for managing product and process regulatory compliance activities while serving as a central point of contact for customer, supplier, government, and other external compliance-related questionnaires and information requests.

This position develops a strong working knowledge of the Company's products, materials, manufacturing processes, supply chain, and regulatory requirements to provide accurate and timely responses and maintain effective compliance programs. The Specialist will work closely with suppliers and cross-functional internal teams to collect, validate, and maintain regulatory documentation and will coordinate with subject matter experts when specialized knowledge is required. This role requires strong attention to detail, excellent organizational skills, regulatory awareness, and the ability to manage multiple compliance activities and deadlines.

This in-office role requires working from our headquarters in Saint Paul, MN.

• Serve as the primary point of contact for customer, supplier, government, and other external questionnaires, surveys, assessments, and information requests related to quality, manufacturing, supply chain, sustainability, regulatory compliance, and Company practices.
• Develop and maintain a strong working knowledge of the Company's processes, policies, procedures, products, and supporting documentation to independently research and respond to routine requests.
• Coordinate with internal subject matter experts across Quality, Operations, Engineering, Supply Chain, Environmental Health & Safety, Human Resources, and other functions to obtain, validate, and document information needed for specialized requests.
• Develop, organize, and maintain a centralized library of completed questionnaires, approved responses, supporting documentation, and other compliance-related information to promote consistency, reduce duplication of effort, and improve response times.
• Monitor incoming requests, establish priorities and deadlines, and ensure responses are complete, accurate, appropriately reviewed, and submitted on time.
• Identify recurring requests, opportunities for standardization, and process improvements that can increase the efficiency and effectiveness of the Company's questionnaire and information-request response process.

• Manage and maintain compliance programs related to REACH, RoHS, California Proposition 65, PFAS, TSCA, and other applicable restricted-substance, chemical-safety, and product regulatory requirements.
• Monitor applicable regulatory requirements and developments and assess their potential impact on Company products, materials, suppliers, and operations.
• Collect, review, and validate supplier declarations, material disclosures, Safety Data Sheets (SDSs), full material disclosure data, regulatory certifications, and other documentation necessary to demonstrate compliance.
• Collaborate directly with suppliers to obtain required compliance documentation, resolve material-related compliance questions, and address discrepancies or gaps in regulatory information.
• Maintain accurate, organized, and current regulatory compliance records, databases, and supporting documentation.
• Support internal and external audits, regulatory inquiries, customer requests, and other compliance-related activities by providing accurate documentation and reporting.
• Provide training and guidance to employees and relevant internal teams regarding applicable regulatory compliance requirements and processes.

• Participate in new part activities and lead PPAP submissions for new or…