Solventum
10,000+ employees
🏥 Healthcare
📦 Logistics
💼 Consulting
Healthcare • Logistics • Consulting
Solventum is a healthcare-focused company renowned for its innovative solutions aimed at improving medical and oral care outcomes. The company offers a variety of medical technologies, including advanced wound care, surgical solutions, and sterilization products. Solventum also provides advanced oral care solutions, health information and technology services, and purification and filtration products for biopharmaceutical applications. Furthermore, Solventum places a strong emphasis on sustainability and education, providing resources and training for healthcare professionals globally. Their commitment to innovation and better healthcare has made them a leader in the healthcare industry, dedicated to enhancing patient safety and healthcare efficiencies.
Principal Regulatory Affairs Specialist
🕒 July 14
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Solventum
10,000+ employees
🏥 Healthcare
📦 Logistics
💼 Consulting
Healthcare • Logistics • Consulting
Solventum is a healthcare-focused company renowned for its innovative solutions aimed at improving medical and oral care outcomes. The company offers a variety of medical technologies, including advanced wound care, surgical solutions, and sterilization products. Solventum also provides advanced oral care solutions, health information and technology services, and purification and filtration products for biopharmaceutical applications. Furthermore, Solventum places a strong emphasis on sustainability and education, providing resources and training for healthcare professionals globally. Their commitment to innovation and better healthcare has made them a leader in the healthcare industry, dedicated to enhancing patient safety and healthcare efficiencies.
📋 Description
• Serving as the regulatory affairs lead on cross‑functional teams • Driving regulatory strategy and execution for Tier 1, high‑volume markets, including the United States, Canada, and the European Union • Conducting global regulatory change assessments • Leading or supporting regulatory filings for continuity and lifecycle projects • Providing regulatory review and input on technical documentation and reports • Contributing to the development, implementation, and continuous improvement of regulatory processes • Supporting risk management, vigilance reporting, and other quality‑related initiatives • Communicating regulatory outcomes and technical information to cross‑functional teams • Supporting the implementation of key corporate initiatives and enabling tools
🎯 Requirements
• Bachelor’s Degree or higher (completed and verified prior to start) • seven (7) years in regulatory affairs experience in the drug and/or medical device industry • Experience authoring regulatory submissions and technical documentation for drug and medical device products in the United States, Canada, and the European Union • Experience authoring regulatory strategies and regulatory change assessments • Experience revising, reviewing, and approving product labeling, including marketing claims, to ensure compliance with global regulatory requirements • Experience with NDA and OTC monograph drugs and medical devices
🏖️ Benefits
• Medical, Dental & Vision • Health Savings Accounts • Health Care & Dependent Care Flexible Spending Accounts • Disability Benefits • Life Insurance • Voluntary Benefits • Paid Absences • Retirement Benefits
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