Regulatory Affairs Specialist II – Medical Devices

Abbott; Saint Paul (MN); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Retirement savings plan

FreeU education benefit

Job summary

Abbott is seeking a Regulatory Affairs Specialist II to join the team on-site in New Brighton, MN. This non-managerial role supports the regulatory department in preparing and submitting documentation for worldwide product registrations, with emphasis on post-market change management.

The candidate will work in a fast-paced, matrixed environment, ensuring adherence to regulatory strategies and quality systems while collaborating with cross-functional teams to meet submission timelines.

Qualifications

• Bachelor’s degree or equivalent combination of education and work experience.
• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals).
• Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Responsibilities

• Analyzes regulatory submissions and input from cumulative product changes.
• Supports regulatory department to ensure compliant processes.
• Prepares and aligns goals with department plans.
• Follows GMP guidelines and procedures.
• Communicates with project groups on regulatory strategies and submission activities.

Skills

Verbal communication

Written communication

Teamwork

Regulatory processes

Education

Bachelor's degree or equivalent

Bachelor's degree in science or related field

Job description

Abbott is seeking a Regulatory Affairs Specialist II to join the team on-site in New Brighton, MN. This non-managerial role supports the regulatory department in preparing and submitting documentation for worldwide product registrations, with emphasis on post-market change management.

The candidate will work in a fast-paced, matrixed environment, ensuring adherence to regulatory strategies and quality systems while collaborating with cross-functional teams to meet submission timelines.