Regulatory Affairs Specialist I - Heart Failure (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

This Regulatory Affairs Specialist I will work on-site out of our Pleasanton, CA location in our Heart Failure Division.  In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

The Opportunity

As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.  This new team member will support necessary regulatory activities required for product market entry.

What You’ll Work On

• Prepares robust regulatory applications (for international regulatory agencies) to achieve departmental and organizational objectives.
• Creates, reviews and approves engineering changes.
• Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the  regulatory agencies to various international affiliates.
• 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 and file systems.  Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• May interface directly with regulatory agencies.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• 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 regulations and regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor’s Degree or an equivalent combination of education and work experience
• Experience with international medical device regulations and submissions.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage, manage and/or engage others to accomplish projects.         
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. 
• Strong organizational and follow-up skills, as well as attention to detail and focus towards impr