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.