Sr Regulatory Affairs Manager, Abbott Ventures - Transcatheter Mitral Valve Replacement (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

Our location in Santa Clara, CA currently has an on-site opportunity for a Senior Regulatory Affairs Manager - Transcatheter Mitral Valve Replacement within Abbott Ventures.  This new team member is responsible for the management and leadership of Regulatory Affairs activities for an early stage Transcatheter Mitral Valve Replacement device. This individual will lead and coordinate global Regulatory Affairs activities including regulatory strategies, submissions to support clinical trial activities and product launches. The Senior Manager leads project submissions for regulatory approvals and acts independently to identify and resolve problems. This individual applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs. The Senior Manager is responsible for estimating, allocating and managing Regulatory Affairs resources to accomplish business and corporate objectives. Knowledge of US FDA requirements and EU MDR requirements as well as other applicable EU regulations as they relate to Class III implantable medical devices is required. Working knowledge of regulatory requirements for Japan, Canada, and other countries is advantageous. The person in this role will manage a team of Regulatory Affairs Specialists, while also managing day-to-day activities, and interacting with individuals across international locations and time zones, cultures and languages.  A portion of time will be dedicated to managerial activities, employee development, strategic oversight and cross-functional alignment to meet regulatory requirements.

What You’ll Work On

• Recruit, coach and develop Regulatory Affairs talent.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of Regulatory Affairs and organizational objectives.
• In collaboration with Regulatory leadership, develops and implements regulatory strategies that will ensure earliest possible introduction of new product(s) into domestic and international markets. 
• Provides direction and guidance to exempt and non-exempt Regulatory Affairs specialists with varied degrees of latitude and independence in their assignments.
• Keeps the organization's vision and values at the forefront of decision making and action.
• Demonstrates effective change management and leadership.
• Builds strategic cross functional partnerships to further Regulatory Affairs and organizational objectives.
• May develop and execute functional 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