Senior Regulatory Affairs Technical Reviewer – Structural Heart (on-site)

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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• 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.

Structural Heart Business Mission:why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

The Opportunity

We are recruiting for a Senior Regulatory Affairs Technical Reviewer to join our team on-site in St. Paul, MN. As an individual contributor, this new team member plays a key role in ensuring labeling content for SH medical device products.  They will be responsible for ensuring accurate, consistent, and compliant language in Instructions for Use (IFUs) based on available clinical and quality evidence.  The Technical Reviewer leads the drafting, review and approval process cross functionally to ensure submission ready documentation to support global and regional requirements as well as support ongoing IFU process improvements.

What You’ll Work On

• Collaborate with the Regulatory team to ensure IFUs meet regulatory compliance and industry best practices.
• Ensure all Structural Heart IFUs use accurate, consistent and compliant language against available clinical and quality evidence. Analyze existing IFUs and implement improvement plans.
• Serves as the subject matter expert (SME) on global IFU regulations.
• Work with cross-functional teams to standardize language for IFU sections applicable to similar products. Track and organize the use of standardized language.
• Ensure consistency between IFUs and other labeling content, such as patient brochures, identification cards, and registration forms.
• Develop and document guidelines for IFU sections, including device descriptions, usage directions, cautions, precautions, contraindications, and warnings.
• Manage and improve IFU related processes and procedures.
• Responsible for leading assigned projects for IFU improvements.
• Supports 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.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor’s Degree or an equivalent combination of education and experience
• 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals).
• 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verbally and in writing. 
• Ability to work in a highly matrixed and geographically diverse environment.
• Has broad knowledge of various technical alternatives and th