Device Regulatory CMC - Manager

his 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 contract role supports global regulatory CMC activities for marketed and development-stage drug-device combination products.You will help shape regulatory strategies and ensure submissions meet applicable requirements across key global markets.The role sits at the intersection of regulatory affairs, device development, quality, clinical, analytical, and human factors teams.You will review technical documentation, contribute to regulatory filings, and provide guidance on product compliance and change controls.The position offers an opportunity to work with complex combination products such as autoinjectors, pre-filled pens, and pre-filled syringes.Success requires strong regulatory judgment, technical understanding, collaboration skills, and the ability to manage multiple priorities effectively.This is a remote opportunity suited to a regulatory professional who thrives in a cross-functional, science-driven environment.