Senior Project Analyst - Diabetes Care

Job description

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.

     

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.
·  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.

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Opportunity

This Senior Project Analyst will work out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

As an individual contributor, the Senior Project Analyst 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.  This new team member may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide.

What You’ll Work On

·  Assist in SOP development and review. 
·  Partner with cross-functional teams to consolidate the coordination, tracking and communication of regulatory submissions, priorities, roadmaps, milestones and status to key stakeholders.
·  Assist in developing regulatory information management system(s) to track regulatory submissions, license renewals etc.
·  Define methodology and tools to measure metrics.
·  Determine and communicate submission and approval requirements.
·  Delivers on project timelines to achieve departmental and organizational objectives.
·  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.
·  Responsible for processes and issuance of Operational aspects in RA, such as Declaration of Conformities, CFGs/COEs, powers of attorney and regulatory letters; document authentication and legalization, etc.
·  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, customers, contractors, and vendors.
·  Maintain annual licenses, registrations, listings and patent information.
·  Assist compliance with product post-marketing approval requirements.
·  Review regulatory aspects of contracts.
·  Contribute to the development and functioning of the crisis/ issue management program.

Required Qualifications

·  Bachelor’s degree or equivalent experience.
·  3-5 years’ experience in a regulated industry. 
·  Gathering user/business requirements
·  Supporting validated IT databases (including data warehouses) and web-based applications.
·  Working knowledge of Systems Development Lifecycle (SDLC) methodology.
·  Working with/in multiple divisions/sites or organizations.
·  Customer focused issue resolution experience.
·  Manufacturing, Engineering, IT, or Laboratory experience in a Quality/Regulatory setting.
·  Project Management experience and use of MS Project and VISIO.
·  Be highly organized, analytical, and detail oriented.
·  Broad knowledge of system and technology alternatives.
·  Development of reporting solutions and utilizing Adhoc reporting tools such as Cognos.

Preferred Qualifications

·  Bachelor’s degree in science, math, engineering, or technology fields. 
·  Advanced level degree
·  Experience with design controls in medical device industry.
·  Experience with working in developing regulatory information management systems.
·  Experience with FDA, EU and other international medical device regulations and submissions.
·  Proficient with Excel, PowerPoint, Power BI and presenting information to leadership
·  Previous experience working in a highly matrixed and geographically diverse business environment
·  Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

     

The base pay for this position is
$83,600.00 – $167,200.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

United States > Alameda : 1360-1380 South Loop Road

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf