Regulatory Affairs Associate - Hybrid - Eagan, MN

Solventum•Eagan, MN

3d•Hybrid

About The Position

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. 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.

Requirements

Bachelor’s Degree or higher from an accredited university
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.
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.
Ensure compliance with corporate policies, procedures and security standards while performing assigned duties.