Senior Regulatory Compliance Specialist
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.
Senior Regulatory Compliance Specialist About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health.
We're always looking towards the future, anticipating changes in medical science and technology.
Working at AbbottAt 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.
The Opportunity This position works out of our Lake Forest, IL location in the Core Lab Division.
Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe.
The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
As the Senior Regulatory Compliance Specialist, you'll provide compliance oversight and guidance for quality systems, quality subsystems and/or key processes.
Incumbent manages compliance activities and assessing impact and/or implementation of new or changing regulations to quality systems for Division, manufacturing sites and/or affiliates.
Facilitate and coordinate inspection/audit readiness activities and communicates progress updates and opportunities for improvements to management as applicable and provides compliance direction for audit action plans.
What You'll Work On Responsible for implementing and maintaining the effectiveness of the quality system.
Lead projects to support Divisional scope; multi-site quality system projects with cross-functional and represent own team while on cross-functional project teams with other functional leaders.
Supports achieving Division goals and strategic initiatives.
Communicates confidently and effectively with management, peers, and key stakeholders, ensuring successful compliance status of the Division, manufacturing sites and/or affiliates.
Interprets regulations and requirements and supports implementation of program and procedures to meet requirements worldwide.
Defines project goals and milestones.
Responsible for timely project completion.
Provide solutions to a wide range of difficult problems.
Ensures solutions are compliant; innovative; thorough; practical and consistent with organizational objectives.
May leads projects with cross-functional broader scope.
Represents team on cross-functional projects with other functional leaders.
Directly influences project direction and scope.
Implements tactical solutions related to assignment.
Able to contribute functional skills and expertise broadly.
Communicates confidently and effectively with management, peers, and key stakeholders.
Contributes functional skills and expertise broadly.
Demonstrates good; general understanding of the standards and regulatory bodies that regulate our industry.
Ensures compliance to Division and Corporate policies and procedures.
Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
Required Qualifications Bachelors degree in Life Science, Engineering, or closely related discipline, or an equivalent combination of education and work experience.
Minimum 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred Qualifications Preferred experience in the Healthcare industry.
Has a history of completing successful cross-functional projects and driving positive compliance outcomes.
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 and @AbbottGlobal.
The base pay for this position is $80,700.
00 - $161,300.
00.
In specific locations, the pay range may vary from the range posted.
Recommended Skills Auditing Biology Engineering Functional Skills Qualification Innovation Stakeholder Management Estimated Salary: $20 to $28 per hour based on qualifications.
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.
Senior Regulatory Compliance Specialist About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health.
We're always looking towards the future, anticipating changes in medical science and technology.
Working at AbbottAt 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.
The Opportunity This position works out of our Lake Forest, IL location in the Core Lab Division.
Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe.
The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
As the Senior Regulatory Compliance Specialist, you'll provide compliance oversight and guidance for quality systems, quality subsystems and/or key processes.
Incumbent manages compliance activities and assessing impact and/or implementation of new or changing regulations to quality systems for Division, manufacturing sites and/or affiliates.
Facilitate and coordinate inspection/audit readiness activities and communicates progress updates and opportunities for improvements to management as applicable and provides compliance direction for audit action plans.
What You'll Work On Responsible for implementing and maintaining the effectiveness of the quality system.
Lead projects to support Divisional scope; multi-site quality system projects with cross-functional and represent own team while on cross-functional project teams with other functional leaders.
Supports achieving Division goals and strategic initiatives.
Communicates confidently and effectively with management, peers, and key stakeholders, ensuring successful compliance status of the Division, manufacturing sites and/or affiliates.
Interprets regulations and requirements and supports implementation of program and procedures to meet requirements worldwide.
Defines project goals and milestones.
Responsible for timely project completion.
Provide solutions to a wide range of difficult problems.
Ensures solutions are compliant; innovative; thorough; practical and consistent with organizational objectives.
May leads projects with cross-functional broader scope.
Represents team on cross-functional projects with other functional leaders.
Directly influences project direction and scope.
Implements tactical solutions related to assignment.
Able to contribute functional skills and expertise broadly.
Communicates confidently and effectively with management, peers, and key stakeholders.
Contributes functional skills and expertise broadly.
Demonstrates good; general understanding of the standards and regulatory bodies that regulate our industry.
Ensures compliance to Division and Corporate policies and procedures.
Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
Required Qualifications Bachelors degree in Life Science, Engineering, or closely related discipline, or an equivalent combination of education and work experience.
Minimum 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred Qualifications Preferred experience in the Healthcare industry.
Has a history of completing successful cross-functional projects and driving positive compliance outcomes.
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 and @AbbottGlobal.
The base pay for this position is $80,700.
00 - $161,300.
00.
In specific locations, the pay range may vary from the range posted.
Recommended Skills Auditing Biology Engineering Functional Skills Qualification Innovation Stakeholder Management Estimated Salary: $20 to $28 per hour based on qualifications.
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