Regulatory Affairs Specialist II — Drive Global Approvals

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

Benefits offered by this job

Health coverage

Retirement plan with employer-contrib

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in New Brighton, MN is seeking a Regulatory Affairs Specialist II to support the regulatory department and ensure compliant processes. The position is on-site and involves preparing documentation for worldwide registrations with emphasis on post-market change management.

You will analyze product changes, coordinate with cross-functional teams, write regulatory submissions, follow GMP guidelines, and contribute to labeling and communications with agencies.

Qualifications

• Bachelor’s degree or equivalent in a related field.
• 2–3 years in a regulated industry (e.g., medical devices, nutritionals).
• Ability to work in a team within a fast-paced, matrixed environment.
• Strong verbal and written communication across multiple levels.
• Judgment within defined practices and policies for regulatory solutions.
• Knowledge of regulatory avenues and ethical standards in business.

Responsibilities

• Analyze input of cumulative product changes to current submissions.
• Share knowledge with department and cross-functional teams.
• Provide solutions requiring evaluation and analysis.
• Prepare goals aligned with department plans and GMP guidelines.
• Write clear regulatory information for external agencies.
• Ensure compliance and effectiveness of the quality system.
• Advise on regulatory strategies for projects and groups.
• Coordinate submission-related activities for product approvals.

Skills

Teamwork

Communication

Regulatory knowledge

Problem solving

Ethical standards

Decision making

Education

Bachelor's degree or equivalent

Science background (biology, chemistry, etc.)

RAC certification (preferred)

Job description

Abbott in New Brighton, MN is seeking a Regulatory Affairs Specialist II to support the regulatory department and ensure compliant processes. The position is on-site and involves preparing documentation for worldwide registrations with emphasis on post-market change management.

You will analyze product changes, coordinate with cross-functional teams, write regulatory submissions, follow GMP guidelines, and contribute to labeling and communications with agencies.