Senior Regulatory Affairs Strategist

Abbott (abbottcareers2 board); New Brighton (MN); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is a global healthcare leader seeking a Senior Regulatory Affairs Specialist to join our team on-site in New Brighton, MN. The role focuses on preparing regulatory submissions, maintaining licenses, and guiding post-market change activities across US/EU regions, collaborating across functions to ensure compliant product lifecycle management.

The ideal candidate brings 3–4 years in regulated industries, strong writing and communication skills, and the ability to navigate complex regulatory

Qualifications

• Bachelor's Degree or an equivalent combination of education and experience.
• 3-4 years' experience in a regulated industry (e.g., medical products, nutritionals).
• 2-3 years of experience in regulatory preferred but may consider related areas.
• Effective communication, preparation, and negotiation with internal teams and authorities.

Responsibilities

• Assist in SOP development and regulatory strategy for product lifecycle planning.
• Monitor regulatory submissions and maintain licenses, registrations, and listings.
• Prepare and submit post-market change submissions and related communications.
• Contribute to regulatory input for recalls, safety reporting, and risk analyses.

Skills

Regulatory writing

Regulatory strategy

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's Degree

Job description

Abbott is a global healthcare leader seeking a Senior Regulatory Affairs Specialist to join our team on-site in New Brighton, MN. The role focuses on preparing regulatory submissions, maintaining licenses, and guiding post-market change activities across US/EU regions, collaborating across functions to ensure compliant product lifecycle management.

The ideal candidate brings 3–4 years in regulated industries, strong writing and communication skills, and the ability to navigate complex regulatory