Structural Heart Regulatory Affairs Specialist II (On-site)

Abbott; New Brighton (MN); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott in New Brighton, MN is seeking a Regulatory Affairs Specialist II to support regulatory submissions for the Structural Heart business unit. The role involves preparing documentation, aligning plans, and ensuring GMP-compliant processes in a collaborative, cross-functional environment.

We value analytical thinking, strong communication, and the ability to navigate regulatory requirements across regions.

Qualifications

• Bachelor’s degree or equivalent in a relevant field; regulatory experience preferred.
• 2–3 years in a regulated industry (medical products, nutritionals) or related area.
• Ability to work in a fast-paced, matrixed environment with strong communication.

Responsibilities

• Analyzes input of cumulative product changes to current submissions.
• Prepares and aligns individual goals with department plans.
• Follows GMP guidelines and submission-related procedures.
• Advises on regulatory strategies and communicates with agencies.

Skills

Teamwork

Communication

Regulatory knowledge

Problem solving

Education

Bachelor's degree or equivalent

Bachelor's degree in science

Job description

Abbott in New Brighton, MN is seeking a Regulatory Affairs Specialist II to support regulatory submissions for the Structural Heart business unit. The role involves preparing documentation, aligning plans, and ensuring GMP-compliant processes in a collaborative, cross-functional environment.

We value analytical thinking, strong communication, and the ability to navigate regulatory requirements across regions.