Regulatory Affairs Associate - Hybrid - Eagan, MN

SOLVENTUM•Eagan, MN

8d•$71,200 - $97,900•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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