Manager Regulatory Compliance

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.
• 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 onsite at our Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease. Our extensive portfolio includes stents, guide wires, balloon dilatation catheters, imaging catheters and hardware/software, vessel preparation devices, vessel closure devices, and thrombectomy devices.

• At the Westford, MA site, the Abbott Vascular team designs, develops, and manufactures products that are used for intravascular imaging. These products include disposable imaging catheters as well as equipment with complex hardware and software.  
• This position is responsible for developing, establishing and maintaining quality systems programs, policies, processes, procedures, training materials, and controls enhancing the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations.

Main Responsibilities

• Provide expert level guidance and direction of the Quality Systems Body-of-Knowledge
• Aggressively identify opportunities to apply, continuously improve, and redefine quality systems and controls for all divisional product-related processes in accordance with applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Provide influential leadership with local and International sites to drive proactive quality system improvements
• Represent Quality Systems as required in support of cross-functional divisional projects.
• Identify Quality Initiatives and lead cross-functional teams to complete them.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance
• Provide management and development of the Quality Systems staff.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback.
• Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.
• Maintains a safe and professional work environment.

Required Qualifications/ Experience

• Bachelors Degree in Science, Engineering or related field (or) an equivalent combination of education and work experience.
• Minimum 10 years in quality functional roles desired with at least 3 years of direct management and supervison of personned and resources.
• Minimum 5 years proven leadership skills, including experience setting goals, providing positive and constructive feedback and improving business results, preferred.
• Minimum 5 years project management, preferred.

     

The base pay for this position is

$97,300.00 – $194,700.00

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

AVD Vascular

        

LOCATION:

United States > Massachusetts > Westford : 4 Robbins Road

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     

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

Salary : $97,300 - $194,700