Regulatory Affairs Associate - Hybrid - Eagan, MN

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

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we’re committed to protecting your personal information—learn more in our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/

Job Description: Regulatory Affairs Associate - Hybrid - Eagan, MN. 3M Health Care is now Solventum. At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients’ lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role

As a Regulatory Affairs Associate, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.

• Support the Medical Surgical (MedSurg) 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.
• Partner with Regulatory Affairs Associates and Specialists to create, update, review, and deactivate device, drug, and cosmetic listings, ensuring accuracy and compliance with FDA requirements.
• Maintain product information and supporting documentation for Certificates to Foreign Government (CFGs).
• Obtain, renew, and maintain Medical Device Manufacturing Licenses and State Wholesale Drug Distribution Licenses.
• Support regulatory certificate requests required for global product registrations, including Certificates to Foreign Government (CFGs), Certificates of Pharmaceutical Product (CPPs), Certificates of Free Sale (CFSs), Letters of Authorization (LOAs), and Powers of Attorney (POAs).
• Coordinate certificate authentication activities, including notarization, apostille, and legalization processes.
• Serve as a liaison between Regulatory Affairs and manufacturing sites to obtain and coordinate site information required for manufacturing site registrations, ensuring regulatory compliance and supporting global product commercialization.
• Monitor and respond to shared email inboxes, addressing inquiries and requests from regulatory authorities, customers, and other stakeholders in a timely manner.
• Support regulatory inspections, audits, and compliance assessments conducted by internal teams and external regulatory authorities.
• Contribute to the development, implementation, maintenance, and continuous improvement of regulatory processes, procedures, and tools.
• Perform additional duties and special projects assigned to support departmental and business objectives.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor’s Degree or higher from an accredited university AND a minimum of one year of experience in Regulatory Affairs in a private, public, government or military environment.

Additional qualifications that could help you succeed even further in this role include:

• 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.
• Soft Skills: Customer service approach to support internal and external customers.

Work location: Hybrid (Job Duties allow for some remote work but require travel to Eagan at least 3 days per week).

Travel: May include up to 10% domestic/international.

Relocation Assistance: NA.

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

Applicable to US Applicants Only

The expected compensation range for this position is $71,200 - $97,900, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience.

In addition, this position may be eligible for a range of benefits.

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

Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.

Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

A new healthcare company with a rich history.

20,000+ employees worldwide.

Operations in 38 countries.

In more than 300 offices and facilities around the world, we work closely with customers and partners to create positive healthcare outcomes that transcend borders.

To realize our shared vision, we harness diverse talents and perspectives from every background to not only address our customers' most urgent priorities but anticipate the needs of the future.