Device Regulatory CMC - Manager

📋 Description

• Review CMC sections of regulatory submissions supporting development and commercial device
• 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
• Collaborate with device product development, quality, clinical development, human factors
• Review device development documentation supporting design controls for drug-device combination
• Provide regulatory assessments and recommendations related to product compliance, change controls

🎯 Requirements

• Bachelor's degree required; preferred fields include Biomedical Engineering, Mechanical
• Approximately 4 years of experience in the medical device, pharmaceutical, or related industry, or
• Experience supporting regulatory submissions or filings for drug-device combination products
• Experience supporting Human Factors studies involving medical devices or combination products.
• Knowledge of combination-product and device regulatory requirements, including FDA requirements, EU
• Familiarity with regulatory guidance and standards from organizations such as FDA, Notified Bodies

🎁 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
• Opportunity to contribute to both development and commercial-stage programs.
• Potential eligibility for overtime pay in accordance with applicable federal and state requirements.