Device Regulatory CMC - Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Device Regulatory CMC - Manager based in United States. This role supports global regulatory CMC activities for marketed and development-stage drug-device combination products. You will help shape regulatory strategies and contribute to high-quality submissions across global markets. The position works closely with multidisciplinary teams spanning device development, quality, clinical, human factors, analytical development, and commercial functions. You will provide regulatory guidance throughout product development and commercialization, helping teams address compliance requirements effectively. The role offers the opportunity to work on combination products such as autoinjectors, pre-filled pens, and pre-filled syringes. You will also contribute to device documentation, design controls, change assessments, and process improvements. Success in this position requires strong regulatory judgment, collaboration, organization, and the ability to translate complex requirements into practical guidance.