Regulatory Affairs Specialist

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 115,000 colleagues serve people in more than 160 countries.

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    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.

This   Regulatory Affairs Specialist   will work out of our Pleasanton, CA location in the Heart Failure Division. As an individual contributor   in   the function of a Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department. With limited   supervision   you will execute tasks and partner across business functions.    As an individual contributor, the Regulatory Affairs Specialist will support product   registration   and regulatory activities .     What   You’ll   Work On      • As   a   professional in the Regulatory Affairs Sub-Function,   possesses   develop ing   skills in product registration submission,   change order   management,   progress reports.     • Interacts with   regulatory affairs team members and   other   cross functional team members   for   regulatory submissions , product   licensing   and   relevant   documentation .     • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.   • Serves   as   regulatory   liaison throughout product lifecycle.     • Ensures   timely   approval of medical devices and continued approval of marketed products.    •   May i nterface with regulatory agencies.    • Conducts reviews of product and manufacturing changes for compliance with applicable regulations.    • Creates,   reviews   and approves engineering change orders.    • Reviews protocols and reports to support regulatory submissions.    • 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       Required Qualifications      Bachelor's Degree (± 16 years), Technical discipline preferred OR an equivalent combination of education and work experience   No