Regulatory Affairs Associate - Hybrid - Eagan, MN

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:

• Supporting the Medical Surgical (Med Surg) Regulatory Operations team in executing regulatory compliance activities and maintaining regulatory records.
• Maintaining FDA Establishment Registrations and product listings for medical devices, drug products, and cosmetics.
• Partnering with Regulatory Affairs Associates and Specialists to create, update, review, and deactivate device, drug, and cosmetic listings, ensuring accuracy and compliance with FDA requirements.
• Maintaining product information and supporting documentation for Certificates to Foreign Government (CFGs).
• Obtaining, renewing, and maintaining Medical Device Manufacturing Licenses and State Wholesale Drug Distribution Licenses.
• Supporting 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).
• Coordinating certificate authentication activities, including notarization, apostille, and legalization processes.
• Serving 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.
• Monitoring and responding to shared email inboxes, addressing inquiries and requests from regulatory authorities, customers, and other stakeholders in a timely manner.
• Supporting regulatory inspections, audits, and compliance assessments conducted by internal teams and external regulatory authorities.
• Contributing to the development, implementation, maintenance, and continuous improvement of regulatory processes, procedures, and tools.
• Performing 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…