Regulatory Operations Specialist I - Abbott Laboratories : Job Details

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.

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'llalso have access to:

· Career development with an international company where you can grow the career you dream of.

· An excellent retirement savings plan with high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program andFreeUeducation benefit - an affordable and convenient path to getting a bachelor's degree.

· Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year

· A company recognized asa great placeto 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.

For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whetherit'sglucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than10,000 peoplehave healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than500,000 peoplewith diabetes from routinefingersticks.

The Opportunity

We are currently hiring a Regulatory Affairs Operations Specialist I to work on-site at our St. Paul or Maple Grove, MN location. This new team member will perform specialized level work assignments and/or analyses,supportingnecessary regulatory activitiesrequiredfor product market entry.

WhatYou'llWork On

· Daily support of product release by preparinglicensingfor products, countries and business partners allowing shipment of product to achieve departmental and organizationalobjectives.

· Responsible for following SOPs,productmarket launches,licensing accuracy, clinicaland distribution, supply planningsupport and overall regulatory operations activities.

· Have a full working knowledge ofproductreleaseandlicensingtypes, country regulatory and language requirements.

· Provide support forRegulatoryAffairsin the set-up for newapprovals,renewalsandreleaseofproducts globally.

· Acts as a regulatory representative responsible for review and analysis of blockedsales and distributionorders, providing guidance and direction on regulatory compliance.

· Reviews and evaluates customer service requests and monitoring ofsharedemail box for such requests,maintaininga high levelof service and follow through on all communications.

· Ensure communications convey all necessary detail and adhere to applicable regulatory standards.

·Maintainspositive and cooperative communications and collaboration with all levels of employees worldwide; customers, contractors, and vendors.

· Have a basic understanding of product lines being supported.

· Have full understanding ofsystems andapplications for research, problem solving and analysis of blocked orders and creation ofproductlicensing.Applications include Windchill and SAP.

· Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing,RegulatoryIn-Country affiliates, US Regulatory partnersand IT.

· Supports all business segment initiatives asidentifiedby divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

·Complies withU.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.

·Participatesin projects affectingproduct releaseand performs other related duties and responsibilities, as assigned

Required Qualifications

· Bachelor's Degree OR an equivalent combination of education or work experience.

· 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 toleverageand/or engage others toaccomplishprojects.

· Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

· Multitasks,prioritizesand meets deadlines intimelymanner.

· Strong organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications

· Bachelor's Degree in a technical discipline.

· Experience with medical device industry.

· Experience working in a broader enterprise/cross-division business unit model.

· Strongproblem solvingskills and ability to think strategically and see the big picture.

· Adaptable with the ability to switch priorities andaccomplishall tasks.

· Process oriented.

The base pay for this position is $50,000.00– $100,000.00. In specific locations, the pay range may vary from the range posted.