Principal Regulatory Affairs Specialist

🔥 6 minutes ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $142.8k - $196.3k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Solventum

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

📚 Education

🧘 Wellness

Healthcare Insurance • Education • Wellness

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

• Leading preparation and submission of 510(k) applications and other regulatory filings for Software as a Medical Device (SaMD) • Developing and executing global regulatory strategies for product registrations in the US, EU (MDR), and Canada • Supporting international regulatory teams with product registrations across the Custom Smiles Portfolio • Ensuring compliance with global regulations and reviewing technical and software documentation for submissions • Collaborating cross-functionally to integrate regulatory requirements into product development

🎯 Requirements

• Bachelor’s Degree or higher and seven (7) years of regulatory affairs experience in medical devices OR High School Diploma/GED and eleven (11) years of regulatory affairs experience in medical devices • Five (5) years of experience with Software as a Medical Device (SaMD) • Experience authoring 510(k) submissions for SaMD • Experience supporting regulatory submissions in the United States and European Union • Master’s degree in Regulatory Affairs (additional qualification) • Experience supporting regulatory submissions in Canada (additional qualification) • Regulatory Affairs Certification (RAC) (additional qualification) • Experience working with dental or orthodontic medical devices (additional qualification) • Experience applying IEC 62304 standards and Software as a Medical Device (SaMD) lifecycle requirements (additional qualification) • Experience preparing and reviewing regulatory documentation and submissions (additional qualification) • Experience communicating regulatory requirements, risks, and outcomes through written reports, presentations, or cross-functional discussions (additional qualification) • Experience collaborating with cross-functional teams (e.g., R&D, Quality, Clinical, and Commercial) to support regulatory activities (additional qualification)

🏖️ Benefits

• Medical • Dental & Vision • Health Savings Accounts • Health Care & Dependent Care Flexible Spending Accounts • Disability Benefits • Life Insurance • Voluntary Benefits • Paid Absences • Retirement Benefits