Director of Manufacturing & Regulatory Affairs

Lavior Pharma Inc. is an innovative medical device company specializing in advanced botanical-based solutions for diabetic wound care and regulated skincare. Our proprietary pharmaceutical-grade formulations are derived from the Inula AGS-RIED botanical species and are developed under rigorous scientific and clinical standards.With over 15 years of research and clinical validation, Lavior’s products are FDA-compliant and designed to address complex chronic conditions including diabetic foot ulcers, burns, eczema, and other advanced skin disorders. Our technologies aim to improve healing outcomes, reduce complications, and elevate standards of care across outpatient, inpatient, and home healthcare settings worldwide.As we expand globally, we are strengthening our manufacturing, quality, and regulatory infrastructure to support scalable and compliant growth.Role DescriptionDirector of Manufacturing & Regulatory AffairsThe Director of Manufacturing & Regulatory Affairs will lead and scale Lavior’s manufacturing and regulatory operations in close collaboration with our US-based ISO 13485-certified contract manufacturer.This executive-level role is responsible for:Ensuring full ISO 13485 quality system complianceOptimizing manufacturing efficiency and scalabilityOverseeing supplier qualification and global sourcing (including China and Mexico)Leading Class I, II, and III regulatory submissionsBuilding a robust, audit-ready operational infrastructure to support international expansionThis is a hands-on leadership role suited for an experienced operator who has successfully worked in growing companies and understands how to scale manufacturing within regulated medical device environments.The Director will report directly to the CEO and play a critical role in supporting Lavior’s global growth strategy.Key ResponsibilitiesManufacturing & Operations LeadershipServe as primary operational lead with US-based contract manufacturerOversee production planning, validation, and batch consistencyImplement KPIs for quality, efficiency, and cost controlLead scale-up initiatives and process optimization effortsEnsure manufacturing documentation and traceability systems are robust and audit-readyQuality & Compliance (ISO 13485)Maintain and improve the Quality Management System (QMS)Develop and refine SOPs, CAPA, change control, and risk management processes (ISO 14971)Prepare for and support regulatory audits and inspectionsEnsure adherence to FDA and international regulatory standardsRegulatory AffairsLead preparation and submission of Class I, II, and III medical device registrationsMaintain technical documentation and regulatory filesEnsure labeling, claims, and product documentation complianceSupport regulatory strategy for new international marketsSupplier Sourcing & QualificationIdentify, evaluate, and qualify global suppliers for bottles, packaging, and componentsConduct supplier audits and establish quality agreementsBalance cost optimization with compliance and quality standardsQualificationsRequired Experience8–15 years of experience in medical device or regulated skincare manufacturingStrong hands-on experience with ISO 13485-certified contract manufacturersDemonstrated experience scaling operations in a growing company environmentDirect involvement in regulatory submissions (Class I–III preferred)Experience managing US-based manufacturing partnershipsTechnical CompetenciesDeep knowledge of production planning and manufacturing process optimizationStrong understanding of Quality Control systems and regulatory complianceExperience implementing and improving QMS frameworksFamiliarity with pharmaceutical-grade or wound care manufacturing processesLeadership & Personal AttributesProven ability to lead cross-functional initiativesStrong operational and strategic thinking capabilitiesExcellent problem-solving skills and attention to detailAbility to build systems and processes in a scaling organizationComfortable working in a fast-paced, high-growth environmentEducationBachelor’s degree in Biomedical, Chemical, Industrial, or Mechanical EngineeringOR Pharmaceutical Sciences / Life SciencesAdvanced degree (MBA or Engineering Master’s) is a strong advantageISO 13485 Lead Auditor or Regulatory certification is a plus

Salary : $141,200 - $186,400