Regulatory Affairs Associate - Hybrid - Eagan, MN

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

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/internati

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.