Senior Regulatory Affairs Specialist – 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:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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.

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 Specialist to join our team on-site in Santa Clara, CA. This new team member will support manufacturing/operations day to day activities for change control and provide consultation/advice to regulatory specialist for change control and product development. This individual will provide regulatory direction/interpretation on team activities as well as interpret and apply regulatory understanding to support the products and teams. The Sr. Specialist will prepare US regulatory submissions and/or registration documents for international affiliates and government agencies worldwide/CE. Additionally, will handle regulatory activities involved in documentation, labeling, field support and applies regulatory and technical knowledge to a wide variety of complex work assignments. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures and maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.

What You’ll Work On

• Executes regulatory requirements in relation to product development, submissions, product maintenance, and project plans.
• Implements Division Regulatory Strategy in specific product related activities.
• Provides risk benefit analyses on a daily basis for specific product area.
• Good understanding of laws and regulations related to the division and applies that basic knowledge and interpretation to the solution of issues and to product development and support.
• Analyzes the input of cumulative product changes to current product submissions.
• Provides solutions to wide variety of difficult problems where analysis requires moderate degree of evaluation.
• Makes presentations to groups division-wide, recommends action or persuades the audience to commit to action, develops formats for reports and presentations. Conducts division-wide regulatory training.
• Makes plans to accomplish multiple activities/ projects, establishes priorities to meet multiple demands, optimizes use of resources.
• Works on developing and improving new planning processes to develop project timelines, including resource requirements to meet project goals.
• Follows GMP guidelines and procedures: Works within all GMP guidelines and procedures.
• Prepares files, modifies and audits documentation to ensure that work is accurate, traceable and complies with all appropriate regulations.
• Shares information with appropriate frequency and timeliness so as to benefit the receiver, keeps parties potentially affected by dec