Regulatory Affairs Associate - Hybrid - Eagan, MN

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

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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

• 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.

• 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.

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 (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

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

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

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here.

A new healthcare company with a rich history. With more than 70 years of delivering healthcare innovations, we continue to move the industry forward by helping to solve our customers’ biggest challenges. 20,000+ employees worldwide. Solventum relies on the courage and the boundless insights of professionals worldwide to achieve exceptional results for our customers and those who rely on them. Healthcare that leads with heart and humility starts with listening and never finishes, only evolves. As long as healthcare challenges remain unsolved, we will be here, united by empathy and a relentless belief that countless lives are improved through our work. Operations in 38 countries. Driven by our dedication to improved outcomes for all we serve, we break through by making unprecedented connections that impact lives. 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.