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 and
• Serve as a regulatory CMC contact for assigned products and projects, providing guidance to
• Collaborate with device product development, quality, clinical development, human factors
• Review device development documentation as needed to support design controls for drug-device
• Provide regulatory assessment and guidance on product compliance topics, including change controls

🎯 Requirements

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Biology, Chemistry, Pharmacy
• Typically 4+ years of experience in the medical device, pharmaceutical, or related industry.
• Demonstrated experience supporting regulatory submissions or filings for drug-device combination
• Experience supporting Human Factors studies involving medical devices or combination products.
• Preferred experience with infusion systems or devices used for drugs or cell therapies.
• Strong knowledge of regulatory requirements for combination products and medical devices, including

🎁 Benefits

• Remote contract opportunity based in the United States.
• Competitive compensation of $75–$80 per hour.
• Opportunity to contribute to global regulatory strategies for complex drug-device combination
• Exposure to development and commercial programs spanning medical device, pharmaceutical, quality
• Opportunity to work with internationally recognized regulatory frameworks and standards.
• Cross-functional environment with collaboration across technical and business teams.