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SUMMARY OF POSITIONThe Combination Product Manager, R&D, is responsible for the development of drug-device combination products using design control and risk management processes. This position will also participate in review of device development, due-diligence of new combination products and investigation of market complaints.ORGANIZATION STRUCTUREThe Combination Product Manager reports to the Executive Director, External R&D. The role interfaces with cross-functional departments including Quality, Regulatory Affairs, Clinical, Pharmacovigilance, Project Management, and Supply Chain as well as cross-companies such as third-party design centers, CMOs, and device component suppliers.RESPONSIBILITIESPrimary responsibilities of this role include the following:1. Design and development of combination products involving device and drug constituent parts using the design control process (in compliance with 21 CFR 820.30 and ISO 13485:2016 section 7.3).2. Preparation, review or update of Design History File (DHF) and risk management file (in compliance with ISO 14971:2019) for the combination products3. Monitoring and review of device constituent part development at the third party design/development house(s) including design reviews and DHF documents review4. Subject matter expert for the due diligence of combination products such as injectable pens, inhalation products, transdermal products, infusions, etc.5. Contribute to the update of commercial combination product design and/or risk files, as needed.6. Partner with Third Party Quality, Combination product to ensure Design History Files and Risk Management Files are complete and compliant7. Support complaint management, pharmacovigilance, and operations to assess product risks and risk reviews.8. Keep abreast of regulatory, cGMP and QSR trends. Stay informed of FDA, EU and ICH Guidelines on drug-device combination products.QUALIFICATIONS1. BS/MS in Engineering (Mechanical or Chemical) or equivalent with 5-7 years of industry experience in the development of combination products (drug & device).2. Two to three years of experience with the development of generic combination products is preferable3. Experience in the preparation, review and/or update of DHF for combination products is desirable.4. Previous work experience should involve developing combination products using design controls including product risk management.5. Strong written and verbal communication skills, specifically in technical writing and oral presentations.6. Capable of working independently based on regulatory requirements, and company goals.*"An Equal Opportunity Employer, including disability/vets." *EOE/M/F/Vet/Disability