Job Description

SUMMARY OF POSITION

The 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 STRUCTURE

The 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.

RESPONSIBILITIES

Primary responsibilities of this role include the following:

  • 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...

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