R&D Manager, Drug/Device Combination

Position SummaryWe are seeking a Combination Product Development Manager to support the development of drug-device combination products. This role is responsible for managing product design, risk management, and regulatory documentation. The position will work closely with internal teams and external partners to ensure products are safe, effective, and compliant.Reporting StructureThis role reports to the Executive Director, External R&D and works with Quality, Regulatory, Clinical, Supply Chain, and external design firms, manufacturers, and suppliers.Key ResponsibilitiesSupport the design and development of drug-device combination products using design control processesPrepare, review, and maintain Design History Files (DHF) and risk management documentationWork with external partners to review product designs and development progressProvide technical support for combination products such as injectors, inhalers, transdermal systems, and infusion devicesEnsure documentation meets regulatory and quality requirementsSupport product risk assessments, complaint investigations, and product improvementsPartner with Quality and other teams to maintain compliant product filesStay current with regulatory requirements and industry standardsQualificationsBS or MS in Mechanical Engineering, Chemical Engineering, or related field5–7 years of experience developing drug-device combination productsInjectables or autoinjectors experience highly preferredExperience with design controls and risk managementExperience with Design History Files (DHF) preferredStrong communication and technical writing skillsAbility to work independently and work with cross-functional teams