Hybrid Regulatory Affairs Associate - MedTech Compliance

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

Job summary

Solventum, a healthcare innovator, is seeking a Regulatory Affairs Associate for a hybrid role in Eagan, MN. You will support regulatory operations, maintain registrations and listings for devices, drugs, and cosmetics, and collaborate across teams to ensure FDA compliance and global product registrations.

Candidates need a Bachelor's degree and at least one year in regulatory affairs; travel up to 10% may be required. Relocation NA; compensation range is $71,200–$97,900 with benefits.

Qualifications

• Bachelor's Degree or higher from an accredited university AND a minimum of one year of Regulatory Affairs experience.
• Knowledge of ISO 13485, MDSAP, EU MDR and similar global regulatory frameworks.
• Experience in medical device or pharmaceutical industries is preferred.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Experience using a Regulatory Information Management Software system.

Responsibilities

• Support the 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 to create, update, review, and deactivate listings, ensuring FDA compliance.
• Maintain product information for CFGs and coordinate regulatory certificates (CFGs, CPPs, CFSs, LOAs, POAs).
• Obtain, renew, and maintain Medical Device Manufacturing Licenses and State Wholesale Drug Distribution Licenses.
• Coordinate certificate authentication activities (notarization, apostille, legalization).
• Serve as liaison between Regulatory Affairs and manufacturing sites for registrations.
• Monitor shared inboxes and respond to regulatory authorities and stakeholders timely.
• Support regulatory inspections, audits, and compliance assessments.
• Contribute to developing and improving regulatory processes and tools.

Skills

Strong organizational skills

Excellent written and verbal comms

Ability to manage multiple priorities

Regulatory information management exp

Customer service mindset

Education

Bachelor's Degree or higher

Job description

Solventum, a healthcare innovator, is seeking a Regulatory Affairs Associate for a hybrid role in Eagan, MN. You will support regulatory operations, maintain registrations and listings for devices, drugs, and cosmetics, and collaborate across teams to ensure FDA compliance and global product registrations.

Candidates need a Bachelor's degree and at least one year in regulatory affairs; travel up to 10% may be required. Relocation NA; compensation range is $71,200–$97,900 with benefits.