Regulatory Affairs Associate - Hybrid - Eagan, MN

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

Job summary

Solventum is seeking a Regulatory Affairs Associate to support regulatory operations for medical devices and pharmaceuticals. The role is hybrid, based in Eagan, MN, with travel as needed.

The candidate will manage registrations, certificates, and documentation to ensure compliance with global regulations. The ideal candidate has a regulatory background, strong organizational skills, and experience with regulatory software.

Qualifications

• Bachelor’s Degree or higher from an accredited university and at least one year of experience in Regulatory Affairs.
• 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 Regulatory Information Management Software.
• Soft Skills: Customer service approach to support internal and external customers.

Responsibilities

• Support the MedSurg Regulatory Operations team in regulatory compliance activities and maintaining records.
• Maintain FDA Establishment Registrations and product listings for medical devices, drugs, and cosmetics.
• Partner with Regulatory Affairs staff to manage device, drug, and cosmetic listings for compliance.
• Maintain product information and documentation for CFGs.
• Obtain, renew, and maintain Manufacturing Licenses and State Wholesale Drug Distribution Licenses.
• Coordinate global regulatory certificates (CFGs, CPPs, CFSs, LOAs, POAs).
• Coordinate certificate authentication (notarization, apostille, legalization).
• Serve as liaison between Regulatory Affairs and manufacturing sites for registrations.
• Monitor and respond to inquiries from authorities and stakeholders in a timely manner.
• Support regulatory inspections, audits, and compliance assessments.
• Contribute to improving regulatory processes, procedures, and tools.
• Perform additional duties and special projects.

Skills

Regulatory Affairs

Medical devices

Documentation

Attention to detail

Communication

Multi-tasking

Regulatory software

Education

Bachelor's Degree or higher

Tools

Regulatory Information Management System

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**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. Here, you will make an impact by:**How you will make an impact*** 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 (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 committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of **@solventum.com**. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.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.**