Hybrid Regulatory Affairs Associate – MedTech

Solventum (3M Healthcare); Eagan (MN); Hybrid; USD 65,000 - 85,000; Full time

Job summary

Solventum in Eagan, MN is seeking a Regulatory Affairs Associate to support regulatory operations for medical devices, drugs, and cosmetics. This hybrid role combines regulatory diligence with hands-on documentation and filings.

You will maintain registrations, coordinate listings, and liaise with manufacturing sites while ensuring FDA compliance and timely responses to authorities. A Bachelor’s degree with regulatory exposure is required, with preference for device/pharma experience.

Qualifications

• Bachelor's degree with 1 year Regulatory Affairs experience.
• Experience in medical device or pharmaceutical industries preferred.
• Knowledge of FDA regulations and global frameworks.
• Strong organizational and communication skills.

Responsibilities

• Support Regulatory Operations team in regulatory compliance activities.
• Maintain FDA Establishment Registrations and product listings.
• Coordinate CFGs, CPPs, CFSs, LOAs, and POAs.
• Liaise between Regulatory Affairs and manufacturing sites for registrations.
• Respond to inquiries from regulators and stakeholders in a timely manner.
• Assist with regulatory inspections and audits.

Skills

Regulatory affairs

Regulatory operations

Attention to detail

Verbal communication

Education

Bachelor's degree or higher

Tools

RIMS software

Job description

Solventum in Eagan, MN is seeking a Regulatory Affairs Associate to support regulatory operations for medical devices, drugs, and cosmetics. This hybrid role combines regulatory diligence with hands-on documentation and filings.

You will maintain registrations, coordinate listings, and liaise with manufacturing sites while ensuring FDA compliance and timely responses to authorities. A Bachelor’s degree with regulatory exposure is required, with preference for device/pharma experience.