Regulatory & Supplier Quality Specialist

JOB TITLE Regulatory & Supplier Quality Specialist DEPARTMENT Quality POSITION REPORTS TO Regulatory Compliance Manager CLASSIFICATION Salaried: [ X ] Hourly: [ ] BASIC PURPOSE OF POSITION The Regulatory & Supplier Quality Specialist supports the company’s regulatory compliance, supplier quality, and Quality Management System activities for medical devices. The position coordinates supplier and external laboratory qualification and monitoring, supplier quality activities, audits, and controlled documentation. Under the direction of the Regulatory Compliance Manager, the position also supports Medical Device Reporting (MDR), recalls and corrections/removals, regulatory activities, and ongoing maintenance and improvement of the Quality Management System. The Specialist works cross-functionally to ensure assigned activities are completed in accordance with applicable regulatory requirements, company procedures, and quality system requirements. ESSENTIAL FUNCTIONS/DUTIES · Coordinate supplier and external testing laboratory qualification, approval, and ongoing monitoring activities. · Support the planning, coordination, conduct, and documentation of supplier, laboratory, and other quality or compliance audits. · Manage assigned supplier quality activities, including supplier evaluations, performance monitoring, requalification, supplier nonconformances, and supplier corrective-action follow-up. · Maintain supplier and laboratory qualification and monitor documentation in accordance with Quality Management System requirements. · Support the Regulatory Compliance Manager with Medical Device Reporting (eMDR) activities, including reportability assessments, regulatory submissions, documentation, and maintenance of applicable records. · Support the Regulatory Compliance Manager with product recall, correction, and removal activities, including regulatory assessments, reporting, documentation, tracking, and effectiveness activities, as applicable. · Support corrective and preventive action plans (CAPAs) related to Regulatory, Compliance, Post Market Surveillance, and Supplier Management activities. · Support administration, maintenance, and continuous improvement of the Quality Management System (QMS). · Support development, review, revision, and implementation of SOPs, work instructions, forms, and controlled documentation related to Regulatory, Compliance, Supplier Management, and QMS activities. · Support the Regulatory Compliance Manager with regulatory activities, including 510(k) submissions, regulatory change assessments, Letters to File, MDALL (Canada), State Licenses, and maintenance of regulatory documentation, as applicable. · Interpret and apply applicable medical device regulatory requirements and recognized standards within assigned responsibilities. · Support internal audits, customer audits, supplier audits, and regulatory inspections, including responses to observations within assigned areas. · Monitor regulatory changes that may affect company products, suppliers, laboratories, or Quality Management System processes. · Partner with Quality, Regulatory, Operations, Engineering, Manufacturing, Supply Chain, and other functions to maintain regulatory and QMS compliance. · Maintain complete, accurate, and inspection-ready records for assigned Regulatory, Compliance, Supplier Management, and Quality System activities. · Provide regulatory and compliance guidance to internal departments within the scope of the position and participate in quality improvement initiatives as assigned. · KEY WORKING RELATIONSHIPS INTERNAL: Works as part of an interdisciplinary team and communicates effectively with Quality, Regulatory, Manufacturing, Operations, Validation, Supply Chain, and other departments. Supports ongoing manufacturing and materials-planning needs while clearly communicating regulatory, supplier quali…

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