Product Stewardship Regulatory Analyst (Solventum)

$119,076 - $145,537/Yr

Solventum Konsult Ab - Eden Prairie, MN

Full-time - Mid Level

Remote - Eden Prairie, MN

About the position

As a Material Continuity Regulatory Analyst at Solventum, you will play a crucial role in ensuring the safety and regulatory compliance of materials used in medical devices and drug products. This position involves collaboration with product stewardship and sourcing teams to evaluate materials, manage regulatory compliance, and communicate project progress to stakeholders. Your expertise will contribute to the development of innovative healthcare solutions that prioritize patient safety and regulatory adherence.

Responsibilities

• Evaluate materials qualified for second sources of supply for medical devices, drug products, and water filtration units.
• Collaborate with product stewardship and R&D teams on reformulation projects and new material inputs to ensure safety and compliance.
• Ensure receipt of third-party certifications for material continuity projects.
• Keep key stakeholders informed of project plans, milestones, progress, and impediments.
• Lead regulatory material analysis with suppliers for compliance requirements, documenting results in management systems.
• Support compliance with regulations such as Hazard Communication, Extended Producer Responsibility (EPR), WEEE/RoHS, and chemical management schemes.

Requirements

• Bachelor's Degree or higher AND three (3) years of combined product stewardship, regulatory affairs, or EHS experience in a private, public, government or military environment OR High School Diploma/GED AND ten (10) years of combined product stewardship, regulatory affairs, or EHS experience.
• 2 years of experience in Safety Data Sheet authoring in Chemical Data Management System (CDMS) and/or ERP systems.

Nice-to-haves

• Master's degree in public health, toxicology, regulatory, engineering, science, or medical field from an accredited institution.
• Five (5) years of product stewardship, regulatory affairs, or clinical studies experience.
• Project management skills or PM certification.
• Experience with global regulations in regulatory or scientific affairs.
• Demonstrated problem-solving skills.
• Strong written and verbal communication skills.
• Interpersonal and influencing skills.
• Knowledge of the medical device industry.

Benefits

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