Consultant For Combination Products Quality Systems And Clinical OperationsWe are seeking an experienced consultant with a strong background in combination products quality systems and clinical operations to support a focused remediation and compliance initiative. This project will involve a comprehensive review of existing Clinical Operations procedures and supporting documentation to assess alignment with combination product development requirements and applicable global regulatory and assess current Clinical Operations SOPs and associated quality documents, including templates, forms, and work instructionsEvaluate whether the existing SOP framework adequately supports combination product development and clinical execution activitiesConduct gap assessments to identify missing, incomplete, overlapping, outdated, or inconsistent procedures and documentationAssess alignment with:21 CFR Part 4 requirementsCombination product quality system expectationsClinical Operations regulatory expectationsApplicable regional and international regulatory considerationsReview and provide recommendations regarding regional requirements across:United StatesEuropean UnionUnited KingdomAustraliaJapanSouth KoreaCanadaSwitzerlandDevelop remediation recommendations and procedural improvement strategies to support compliance, inspection readiness, and operational efficiencyCollaborate cross-functionally with Quality, Regulatory Affairs, Clinical Operations, and other stakeholders to support project objectivesProvide clear documentation of findings, risk areas, and recommended corrective actionsQualificationsBachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or a related discipline7+ years of experience in the medical device, pharmaceutical, biotechnology, or combination products industryDemonstrated experience with combination product quality systems and Clinical Operations processesStrong working knowledge of 21 CFR Part 4 and applicable global regulations related to combination productsHands-on experience performing SOP reviews, gap assessments, remediation activities, and procedural harmonization projectsExperience supporting global or multi-regional regulatory and quality compliance initiativesFamiliarity with regional regulatory considerations across the US, EU, UK, Australia, Japan, South Korea, Canada, and Switzerland preferredStrong understanding of design controls, risk management, and clinical development processes for combination productsExcellent technical writing, communication, and stakeholder collaboration skillsAbility to work independently and provide strategic recommendations in a consulting environmentPrior experience supporting combination product clinical development programsExperience preparing organizations for inspections or regulatory auditsBackground in quality system remediation or quality transformation initiativesExperience working within highly regulated environments supporting both device and pharmaceutical requirementsLocationRemoteEmployment TypeConsultingAbout Ventura SolutionsVentura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp-to-permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at Opportunity Employer Minorities/Women/Veterans/Disabled
Experience: 7 years required