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.

　　Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

　　The position of Compliance Specialist is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. The Compliance Specialist is responsible for maintaining and strengthening the Quality management system. The Compliance team manages the documentation system, systems for laboratory quality, internal and external audit programs, pest control, and the sanitation program. Develops and keeps all quality management systems in line with relevant laws & regulations through audit reporting and corrective actions, validation and verifications and sanitation program administration. The Compliance Specialist focuses on development of quality systems including coordination and implementation of new and existing

　　processes.

　　This job description will be reviewed periodically and is subject to change by management.

　　RESPONSIBILITIES:

　　Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.

　　Ensures compliance to the requirements from regulatory agencies.

　　Maintains the technical and non-technical documentation change system.

　　Assures procedures are in place to classify and maintain records.

　　Interprets and enforces all documentation formatting, standards, policies, and

　　operating procedure requirements.

　　May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers.

　　May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.

　　May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.

　　BASIC QUALIFICATIONS | EDUCATION:

　　Associate degree in biology, Chemistry, Science or equivalent experience.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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 base pay for this position is $48,000.00 – $96,000.00. In specific locations, the pay range may vary from the range posted.

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]