Senior Regulatory Affairs Specialist – Heart Failure; on-site

Overview

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.

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.

Our mission is to help people with heart failure survive and thrive. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment.

We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in Pleasanton, CA. This team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide.

The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

• Develops worldwide strategies for regulatory approval of new and modified products.
• Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives. Coordinates, compiles, and submits regulatory submissions, including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product registrations.
• Represents Regulatory Affairs on cross-functional product development and manufacturing support teams. Guides teams to provide content for submissions and participates in design reviews as needed.
• Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
• Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities.
• Reviews, edits, and approves Advertising and Promotional materials.
• Acts as liaison between the Company and in-country affiliates as well as the various regulatory agencies, ensuring that communications are relevant, specific and convey all necessary detail.
• Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current, up-to-date and are entered into the regulatory submission database and file systems. Ensures that details of any new or modified regulations are distributed to appropriate personnel.
• Supports the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release.
• Interfaces directly with regulatory agencies as needed.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Communicates with and maintains productive, constructive relationships with external customers as required – regulatory…