Quality and Regulatory Manager

About Partners Dental SolutionsPartners Dental Solutions is a growing dental manufacturing organization focused on building high-quality, consistent, and scalable products. As we continue to expand, we are investing in strengthening our quality systems and regulatory foundation to support future FDA pathways and long-term growth. Position OverviewWe are seeking a Quality & Regulatory Manager to own internal quality systems and support regulatory readiness as we build toward FDA compliance and submission activities. This role will lead the development of a Quality Management System (QMS), ensure alignment with FDA and ISO 13485 standards, and manage documentation, audit readiness, and regulatory coordination. The position will support regulatory readiness and may partner with external regulatory experts as needed to advance FDA 510(k) submission efforts. This role will play a key part in preparing the organization for FDA 510(k) submission, including supporting documentation strategy, design controls, and regulatory readiness in partnership with external experts. This is a hands-on role focused on execution, organization, and building systems that support compliant manufacturing. Key ResponsibilitiesQuality SystemsBuild and implement a Quality Management System aligned with FDA 21 CFR Part 820 and ISO 13485Establish and maintain SOPs, document control systems, and quality recordsDevelop and support Device Master Records (DMR) and Design History Files (DHF)Lead CAPA, risk management, and change control processesSupport implementation of Design Controls in alignment with FDA requirements, including traceability, verification, and validation activitiesEnsure documentation is complete, accurate and audit-readyRegulatory Support & CoordinationSupport preparation for FDA 510(k) submission activities, including documentation, organization, and regulatory readiness; collaborate with external regulatory experts as neededOrganize and maintain regulatory documentation and technical filesSupport device classification research and regulatory development (Class I, II, III) in collaboration with external consultantsTranslate regulatory requirements into practical internal processesTrack timelines, deliverables, and regulatory milestones Cross-Functional LeadershipPartner with Operations, Design and Manufacturing teams to implement compliant processesProvide training and guidance on quality and documentation standardsServe as internal subject matter resource for quality and regulatory requirementsWorkplace SafetyPartner with Operations to support OSHA compliance and safety programs as neededAudit and Inspection SupportPrepare the organization for FDA, ISO, OSHA and internal auditsConduct mock audits and identify gapsServe as the primary liaison during external audits and inspectionsLead and track corrective actions to closureWhy This Role is ExcitingThis role offers the opportunity to build quality and regulatory systems from the ground up and play a direct role in shaping Partners Dental Solutions’ FDA pathwayQualificationsBachelor’s degree in Quality, Regulatory Affairs, Engineering, or related field5-7 years of experience in quality and/or regulatory roles within, medical device, dental, or manufacturing environmentsWorking knowledge of FDA 21 CFR Part 820, OSHA standards, ISO 13485, and Good Manufacturing Practices (GMP)Experience with documentation systems, SOPs, and audit preparationExcellent project management, organizational, and communication skillsAbility to lead cross-functional initiatives and drive a culture of quality and safetyWhat Success Looks Like (First 6-12 Months)QMS structure established and aligned with FDA and ISO expectationsSOPs, DMR, and DHF frameworks implemented and organizedDocumentation is audit-ready and consistently maintainedStrong partnership established with regulatory consultantClear progress toward regulatory submission readiness