Hybrid Regulatory Affairs Associate — MedTech & Global Compliance

Solventum in; Eagan (MN); Hybrid; USD 71,000 - 98,000; Full time

Job summary

Solventum, a new healthcare company, is seeking a Regulatory Affairs Associate in Eagan, MN. This hybrid role supports regulatory operations for medical device, drug, and cosmetics listings, registrations, and certifications, collaborating with cross-functional teams to ensure compliance.

The ideal candidate has a Bachelor's degree and at least one year of Regulatory Affairs experience, strong knowledge of ISO 13485/MDSAP/EU MDR, and experience with Regulatory Information Management software.

Qualifications

• Bachelor’s Degree or higher and at least 1 year in Regulatory Affairs.
• Knowledge of ISO 13485, MDSAP, EU MDR and other global regulatory frameworks.
• Experience in medical device or pharmaceutical industry.
• Strong organizational and communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience using Regulatory Information Management Software.

Responsibilities

• Support Regulatory Operations in executing regulatory compliance activities and maintaining regulatory records.
• Maintain FDA Establishment Registrations and product listings for medical devices, drug products, and cosmetics.
• Coordinate listings for device, drug, and cosmetic listings with accuracy and compliance.
• Maintain CFGs and related documentation.
• Obtain and renew Medical Device Manufacturing Licenses and State Wholesale Drug Distribution Licenses.
• Coordinate regulatory certificate requests for global registrations (CFGs, CPPs, CFSs, LOAs, POAs).
• Coordinate certificate authentication (notarization, apostille, legalization).
• Liaise between Regulatory Affairs and manufacturing sites for registrations.
• Monitor inboxes and respond to inquiries from authorities and stakeholders.
• Support regulatory inspections, audits, and assessments.
• Contribute to regulatory process improvements and tools.

Skills

Regulatory affairs experience

Knowledge of ISO 13485 / MDSAP / EU Mx

Organizational skills

Communication skills

Multitasking in fast-paced environment

Customer service approach

Education

Bachelor’s Degree or higher

Tools

Regulatory Information Management Software

Job description

Solventum, a new healthcare company, is seeking a Regulatory Affairs Associate in Eagan, MN. This hybrid role supports regulatory operations for medical device, drug, and cosmetics listings, registrations, and certifications, collaborating with cross-functional teams to ensure compliance.

The ideal candidate has a Bachelor's degree and at least one year of Regulatory Affairs experience, strong knowledge of ISO 13485/MDSAP/EU MDR, and experience with Regulatory Information Management software.