Regulatory Affairs Associate — Hybrid, MedTech Impact

USA SOLVENTUM US LLC; Eagan (MN); Hybrid; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical

Dental & Vision

Health Savings Accounts

Health Care & Dependent Care Flexible

Disability Benefits

Life Insurance

Voluntary Benefits

Paid Absences

Retirement Benefits

Job summary

Solventum in Eagan, MN is seeking a Regulatory Affairs Associate to support FDA registrations, device and drug listings, and global regulatory submissions in a hybrid role with some remote work.

You will collaborate with the Regulatory Operations team, coordinate certifications (CFGs, CPPs, CFSs, LOAs, POAs), respond to authorities, and help maintain registrations across manufacturing sites while traveling to Eagan three days a week.

Qualifications

• Bachelor’s degree or higher and at least one year of Regulatory Affairs experience.
• Familiarity with ISO 13485, MDSAP, EU MDR or similar global frameworks.
• Excellent written and verbal communication and attention to detail.

Responsibilities

• Maintain FDA Establishment Registrations and product listings for medical devices, drugs, and cosmetics.
• Coordinate CFGs, CPPs, CFSs, LOAs, and POAs for global registrations.
• Support regulatory inspections and audits by internal teams and authorities.
• Collaborate with manufacturing sites to obtain and coordinate site information for registrations.
• Respond to inquiries from authorities and customers in a timely manner.

Skills

Regulatory Affairs experience

FDA/regulatory compliance

Documentation management

Communication skills

Education

Bachelor’s degree or higher in a relevant field

Tools

Regulatory Information Management Software

Job description

Solventum in Eagan, MN is seeking a Regulatory Affairs Associate to support FDA registrations, device and drug listings, and global regulatory submissions in a hybrid role with some remote work.

You will collaborate with the Regulatory Operations team, coordinate certifications (CFGs, CPPs, CFSs, LOAs, POAs), respond to authorities, and help maintain registrations across manufacturing sites while traveling to Eagan three days a week.