Regulatory Affairs Associate

Solventum

. Support the Medical Surgical Regulatory Operations team in executing regulatory compliance activities and maintaining regulatory records .

Posted 9/16/2026full-timeEagan • Minnesota • United StatesJuniorMid-Level💰 $71,200 - $97,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a focus on compliance activities for medical devices and pharmaceuticals, including knowledge of global regulatory frameworks and strong organizational skills. Proficient in managing regulatory records and supporting internal and external customer inquiries.

Highest-signal resume keywords

Regulatory Affairs ExperienceKnowledge of ISO 13485Experience in Medical Device IndustryRegulatory Information Management SoftwareStrong Organizational Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Compliance ActivitiesFDA Establishment RegistrationsProduct Listings ManagementMedical Device Manufacturing LicensesGlobal Product RegistrationsCertificate AuthenticationRegulatory Inspections SupportRegulatory Processes ImprovementDocumentation MaintenanceAttention to Detail

Soft Skills

Excellent Written CommunicationExcellent Verbal CommunicationCustomer Service ApproachAbility to Manage Multiple Priorities

Tools & Technologies

Regulatory Information Management Software

Industry Keywords

Medical DevicesPharmaceutical IndustryRegulatory FrameworksMDSAPEU MDRCertificates to Foreign GovernmentNotarizationApostilleLegalization ProcessesCompliance Assessments

About the role

Key responsibilities & impact

Support the Medical Surgical Regulatory Operations team in executing regulatory compliance activities and maintaining regulatory records
Maintain FDA Establishment Registrations and product listings for medical devices, drug products, and cosmetics
Create, update, review, and deactivate device, drug, and cosmetic listings in compliance with FDA requirements
Maintain product information and supporting documentation for Certificates to Foreign Government
Obtain, renew, and maintain Medical Device Manufacturing Licenses and State Wholesale Drug Distribution Licenses
Support regulatory certificate requests for global product registrations, including CFGs, CPPs, CFSs, LOAs, and POAs
Coordinate certificate authentication activities, including notarization, apostille, and legalization processes
Liaise with Regulatory Affairs and manufacturing sites to obtain information for manufacturing site registrations
Monitor and respond to shared email inboxes and stakeholder inquiries
Support regulatory inspections, audits, and compliance assessments
Contribute to the development, implementation, maintenance, and improvement of regulatory processes, procedures, and tools
Perform additional duties and special projects supporting departmental and business objectives
Comply with corporate policies, procedures, and security standards

Requirements

What you’ll need

Bachelor’s Degree or higher from an accredited university
Minimum of one year of experience in Regulatory Affairs in a private, public, government or military environment
Knowledge of ISO 13485, MDSAP, EU MDR, and other global regulatory frameworks
Strong organizational skills and attention to detail
Excellent written and verbal communication skills
Experience in medical device or pharmaceutical industry
Ability to manage multiple priorities and meet deadlines in a fast-paced environment
Experience using a Regulatory Information Management Software system
Customer service approach to support internal and external customers
Must be legally authorized to work in country of employment without sponsorship for employment visa status

Benefits

Comp & perks

Medical, Dental & Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Voluntary Benefits
Paid Absences
Retirement Benefits
Variable incentive pay, if eligible
Hybrid work arrangement with some remote work
Travel may include up to 10% domestic/international