Solventum
Solventum is a healthcare company that develops innovative products and services aimed at improving patient outcomes and enhancing the efficiency of healthcare. The company offers a wide range of solutions including advanced wound care, oral care, health information and technology, and purification and filtration systems. Solventum is committed to evidence-based care and continuous healthcare education, providing support through peer-to-peer programs and innovative developments such as 3D printed aligner attachments. It places a strong emphasis on sustainability, aiming for 100% renewable electricity by 2030. With a focus on enabling better, smarter, safer healthcare, Solventum works closely with healthcare professionals to address chronic health needs and provide trusted, leading brands.
Senior Regulatory Affairs Specialist
April 9
Solventum
Solventum is a healthcare company that develops innovative products and services aimed at improving patient outcomes and enhancing the efficiency of healthcare. The company offers a wide range of solutions including advanced wound care, oral care, health information and technology, and purification and filtration systems. Solventum is committed to evidence-based care and continuous healthcare education, providing support through peer-to-peer programs and innovative developments such as 3D printed aligner attachments. It places a strong emphasis on sustainability, aiming for 100% renewable electricity by 2030. With a focus on enabling better, smarter, safer healthcare, Solventum works closely with healthcare professionals to address chronic health needs and provide trusted, leading brands.
📋 Description
• Senior Regulatory Affairs Specialist position at Solventum leading regulatory efforts for 3M & Solventum spin-off for Medical Surgical business. • Conducting global regulatory change assessments and coordinating activities for assigned products. • Supporting global regulatory strategies related to spin-off continuity projects. • Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality. • Providing regulatory review of technical reports and documents. • Leading regulatory filings for continuity projects (EU/USA, Canada, and supporting ROW). • Communicating results of technical tasks to teams, respective business group(s) and/or country/region served.
🎯 Requirements
• Bachelor’s Degree in scientific discipline (e.g. Chemistry, Chemical Engineering) or higher AND Minimum seven (7) years of experience in regulatory affairs in the drug (pharmaceutical) and medical device industry including experience working on combination medical devices. • OR High School Diploma/GED from AND (14) fourteen years of experience in regulatory affairs in the medical device industry • Direct experience authoring regulatory submissions/technical documentation • Direct experience authoring regulatory strategies and regulatory change assessments • Experience working with regulatory support for wound dressings and/or surgical products • Experience working and providing regulatory support for new product development teams • Experience developing regulatory strategies, label and claims review and project management. • Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devices, proficient in Office Suite and Regulatory Management Software
🏖️ 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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