Sr. Manager Regulatory Affairs

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.

The Opportunity

This position works out in our facilities of Santa Clara CA in the Diagnostics Division. 

We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

What You’ll Work On

We are recruiting for a SENIOR MANAGER REGULATORY AFFAIRS to join the Regulatory team at the Santa Clara, CA location.  In this role, you be responsible for coordinating, planning, preparation, assembly, and review of regulatory strategies and submissions to the FDA, Notified Bodies, and other worldwide regulatory agencies as well as daily regulatory operations.

 

What you will do: 

• Recruits, coaches, and develops organizational talent.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
• May supervise non-exempt employees.
• Keeps the organization's vision and values at the forefront of decision making and action.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organizational objectives.
• Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
• Develop regulatory strategies, clearance/approval schedules, and submission standards to achieve departmental and organizational objectives.
• Assess proposed regulations and communicate new requirements to the organization.
• Conducts and supports necessary regulatory activities required for product market entry of instrument hardware/software and reagents. 
• Conduct reviews of product design and manufacturing changes for compliance with applicable regulations. 
• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.  Provides guidance and expertise. 
• Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base