Regulatory Operations Specialist I - Structural Heart

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.

The Opportunity

Abbott's Structural Heart 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.

We are seeking a Regulatory Operations Specialist I for our St. Paul, MN location to perform specialized level work assignments and/or analyses, evaluation, preparation and general support of global regulatory activities.

What You’ll Work On

• Daily management Product Release Authorization (PRA) activities allowing shipment of product to achieve departmental and organizational objectives, including maintaining accurate master data, ZFIN selection, PRA Checklists, and proper approvers for assigned regions.

• Serve as a regulatory representative, reviewing and analyzing GTS blocked orders, and coordinate activities to resolve issues. Reporting out to management status of any high priority product release activities.

• Maintain a basic understanding of product lines and organize product information for internal procedures, reporting, quality plans, and audit needs.

• Understand and utilize Windchill and other business systems for change control, documentation control, and other Regulatory Affairs interactions.

• Complete other Regulatory Operations daily support tasks when assigned, such as data clean up, quality system documentation, training, audit support, CAPA, system enhancements, etc.

• Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates and IT.

• 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, customers, contractors, and vendors.

Qualifications

• Prefer bachelor's or associate degree within STEM field
• Related experience, preferably a minimum of one year in Medical Device industry
• Experience with ERP and/or PLM systems such as SAP and/or Windchill
• Knowledge with Medical Device Quality Management Systems (QMS) and Good Documentation Practice (GDP)
• Proficient with MS Office suite (Word, Excel, Outlook)
• 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 collaborate and work cross functionally
• Strong organizational and follow-up skills, as well as attention to detail
• Multita