Regulatory Affairs Specialist II, Structural Heart Devices

Abbott (abbottcareers2 board); New Brighton (MN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Free medical coverage

Excellent retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Regulatory Affairs Specialist II to join our New Brighton, MN team on-site. As an individual contributor, you will support regulatory submissions, prepare documentation for registrations worldwide, and assist in post-market change management to ensure compliance. You’ll work with cross-functional teams and align goals with department priorities.

You’ll also help implement GMP guidelines, draft clear regulatory communications, and coordinate with external agencies as needed.

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, R&D/support, scientific affairs, operations, or related area.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Has a sound knowledge of a variety of alternatives and their impact on the business.

Responsibilities

• Analyzes the input of cumulative product changes to current product submissions.
• Shares knowledge with others in department and on cross-functional teams.
• Provides solutions to a variety of problems where analysis requires moderate degree of evaluation.
• Prepares and aligns individual goals with department goals.
• Establishes and executes against project goals and implements plans.
• Follows GMP guidelines and procedures.

Skills

Regulatory experience

Cross-functional collaboration

Strong written/verbal communication

GMP knowledge

Education

Bachelor’s degree or equivalent combination of education and work experience

Bachelor’s degree in science, math, engineering, or medical fields

Job description

Abbott is seeking a Regulatory Affairs Specialist II to join our New Brighton, MN team on-site. As an individual contributor, you will support regulatory submissions, prepare documentation for registrations worldwide, and assist in post-market change management to ensure compliance. You’ll work with cross-functional teams and align goals with department priorities.

You’ll also help implement GMP guidelines, draft clear regulatory communications, and coordinate with external agencies as needed.