Senior Regulatory Affairs Specialist – Global Medical Devices

Abbott; New Brighton (MN); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott, a global healthcare leader, is recruiting a Senior Regulatory Affairs Specialist to join on-site in New Brighton, MN. You will support the regulatory department to ensure compliant business processes and global product registrations.

Key responsibilities include developing regulatory strategy, preparing US/EU post-market submissions, maintaining licenses, and coordinating with international affiliates. Strong writing and communication with regulatory authorities are required.

Qualifications

• Bachelor’s degree or equivalent education/experience.
• 3–4 years in a regulated industry (medical products, nutritionals).
• 2–3 years regulatory experience preferred; may consider QA or related areas.
• Strong written and verbal communication with regulators.
• Ability to work in a highly matrixed, global environment.
• Broad knowledge of regulatory alternatives and their business impact.
• Define regulatory strategy with supervision.
• Follow scientific arguments and identify data needs with supervision.

Responsibilities

• Assist in regulatory strategy development and lifecycle planning.
• Prepare and submit US/EU post-market change submissions.
• Maintain annual licenses, registrations, listings and patent information.
• Interact with regulatory authorities during development and review processes.
• Contribute to crisis/issue management and recalls input.
• Medical writing, labeling, advertising and regulatory documentation.

Skills

Regulatory affairs

Technical writing

Regulatory strategy

Communication

Cross-functional collaboration

Education

Bachelor’s degree

Master’s preferred

Job description

Abbott, a global healthcare leader, is recruiting a Senior Regulatory Affairs Specialist to join on-site in New Brighton, MN. You will support the regulatory department to ensure compliant business processes and global product registrations.

Key responsibilities include developing regulatory strategy, preparing US/EU post-market submissions, maintaining licenses, and coordinating with international affiliates. Strong writing and communication with regulatory authorities are required.