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.

Review CMC sections of regulatory submissions supporting development and commercial device programs, ensuring content is accurate, complete, and aligned with applicable requirements. Contribute to global regulatory CMC strategies for commercial drug-device combination products. Serve as a regulatory CMC contact for assigned products and projects and provide guidance to cross-functional stakeholders. Collaborate with device product development, quality, clinical development, human factors, analytical development, and marketing teams. Review device development documentation supporting design controls for drug-device combination products. Provide regulatory assessments and recommendations related to product compliance, change controls, and process improvements. Help ensure global regulatory requirements are appropriately incorporated into development and commercial programs. Communicate complex regulatory information clearly and provide practical guidance to stakeholders and management. Requirements Bachelor’s degree required; preferred fields include Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or another relevant life-science discipline. Approximately 4 years of experience in the medical device, pharmaceutical, or related industry, or an equivalent combination of education and experience. Experience supporting regulatory submissions or filings for drug-device combination products, particularly autoinjectors, pre-filled pens, and/or pre-filled syringes. Experience supporting Human Factors studies involving medical devices or combination products. Knowledge of combination-product and device regulatory requirements, including FDA requirements, EU MDR, and applicable GSPRs. Familiarity with regulatory guidance and standards from organizations such as FDA, Notified Bodies, MDCG, EMA, and ISO. Strong knowledge of Design Controls, cGMP, and relevant standards including ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, and ISO 11040. Preferred experience with infusion systems or devices used with drugs or cell therapies. Strong interpersonal and communication skills, with the ability to exchange complex information and guide cross-functional teams. Strong problem-solving, planning, prioritization, and organizational skills, with the ability to work effectively across different levels of management. Ability to collaborate openly and communicate in a clear, complete, timely, and consistent manner. Benefits Contract opportunity with an estimated compensation range of $75–$80 per hour . Remote work opportunity within the United States. Opportunity to support global regulatory strategies for innovative drug-device combination products. Exposure to multidisciplinary teams across regulatory, engineering, quality, clinical, human factors, analytical, and commercial functions. Opportunity to contribute to both development and commercial-stage programs. Potential eligibility for overtime pay in accordance with applicable federal and state requirements. Compensation and any applicable benefits are provided according to the terms of the third-party employment arrangement.

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