Quality & Regulatory Specialist (ISO 9001 / ISO 13485)

Job Description Quality & Regulatory Specialist (ISO 9001 / ISO 13485)Position SummaryWe are seeking a detail-oriented Quality & Regulatory Specialist with hands-on experience in ISO 9001 and ISO 13485 within a regulated environment. This role supports the maintenance and continuous improvement of the Quality Management System (QMS) to ensure compliance with U.S. and international regulatory standards.This position is ideal for someone who is highly organized, process-driven, and experienced in quality systems, with the ability to support cross-functional teams and assist with production, quality, and regulatory initiatives.Key ResponsibilitiesSupport and assist managers with maintaining and improving the Quality Management System (QMS) in compliance with ISO 9001 and ISO 13485Assist managers with ensuring adherence to regulatory requirements including FDA (21 CFR Part 820) and IVDR (EU 2017/746)Assist managers with internal and external audits, including preparation, coordination, and follow-up actionsSupport CAPA activities, including tracking, documentation, and follow-up to ensure timely resolutionMaintain document control processes, including SOP creation, revisions, and change managementAssist managers with regulatory documentation, technical files, and inspection readinessSupport monitoring of production processes, product quality, and risk management activitiesCoordinate calibration, maintenance, and quality control processes to support proper equipment and system functionalityAssist with reviewing customer feedback, complaints, and non-conforming products; support trend tracking and corrective actionsSupport supplier quality activities, including vendor documentation, qualification support, and audit coordinationTrack quality metrics, quality objectives, and continuous improvement initiativesMaintain traceability records, inventory quality documentation, and QMS filesCoordinate and assist with delivery of quality and regulatory training; maintain employee training matrixPartner with operations, engineering, production, and regulatory teams to support alignment and complianceAssist managers with preparing for management reviews and compiling quality data and reportsQualificationsBachelor's degree in a related field or equivalent experience2+ years of experience in quality management or regulatory complianceWorking knowledge of ISO 9001 and ISO 13485 (required)Experience with IVDR or IVD regulatory environments (preferred, not required)Experience in a regulated environment (medical device, manufacturing, or IVD preferred)Familiarity with FDA regulations (21 CFR Part 820) is a plusExperience with CAPA, audits, document control, and QMS systemsProficiency in Microsoft Office (Excel, Word, Outlook) requiredStrong attention to detail, organization, and problem-solving skillsAbility to manage multiple priorities in a fast-paced environmentStrong communication skills and ability to work cross-functionallyPreferred QualificationsExperience in medical device or IVD manufacturingExposure to EU regulatory submissions and technical documentationExperience with electronic QMS systemsFamiliarity with risk management tools (FMEA, root cause analysis)What Success Looks LikeQMS documentation and processes are consistently maintained and audit-readyCAPA tracking, audits, and documentation are completed accurately and on timeStrong support provided to managers and cross-functional teamsContinuous improvements that enhance efficiency, compliance, and product qualityHiring TimelineWe are actively interviewing and looking to make a hire within the next 1–2 weeks. Qualified candidates are encouraged to apply immediately.