International Regulatory Affairs Specialist I - Medical Devices (onsite)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

The Opportunity

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

We are currently hiring an International Regulatory Affairs Specialist I to work on-site at our Plymouth, MN location. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.  Additionally, will support necessary regulatory activities required for product market entry.

What You’ll Work On

• Assist in the preparation of International regulatory applications (including annual reports) to achieve departmental and organizational objectives.
• Review applicability of International medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.  Ensure that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.
• Determine and communicate submission and approval requirements and timelines to project teams.
• Evaluate proposed preclinical, clinical, design and manufacturing changes for regulatory submission strategies.
• Provide Regulatory impact assessment for changes to already licensed product for assigned international regions.
• Act as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
• Work across functions to develop documents or required product information for successful regulatory submission.
• Assist with label development and review for compliance before release
• Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Exercise judgment in selecting innovative, practical methods to achieve problem resolution.
• Support all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Required Qualifications

• Bachelor’s Degree OR an equivalent combinatio