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 109,000 colleagues serve people in more than 160 countries.
A healthy heart is essential to good health. That’s why we’re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people’s health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Our location in Sylmar, CA or Plymouth or Minnetonka, MN currently has an opportunity for a Regulatory Compliance Manager.
This position is responsible for planning and executing field corrective actions, as well as the quality systems processes and procedures, training materials, and controls that support execution of field corrective actions in conformance to established standards and agency regulations.
WHAT YOU’LL DO
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Plan, lead, execute and close reportable field actions as the field action coordinator
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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.
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Provide influential leadership with local and International sites to drive execution of field actions
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Represent Global Strategic Compliance in support of cross-functional divisional projects
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Assess resource needs as part of field action planning and execution to assure that the accurate level of support is provided when needed with the competencies needed
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Maintain effective quality metrics related to Health Hazard Evaluations (HHEs) and field actions and propose activities to resolve decreases in performance
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Sets goals which align to department plans and manages the execution of goals through coaching and mentoring
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Maintains a safe and professional work environment
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
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Bachelors Degree in Science, Engineering or related field or an equivalent combination of education and work experience.
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Minimum 5 years of experience in a quality functional role or regulated industry with at least 3 years of direct management and supervision of personnel and resources
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5 years of Project Management experience
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Ability to lead cross functional, often international teams made up of stakeholders with different, sometimes conflicting, priorities, questions, motives and concerns
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Ability to present in front of senior levels of the organization
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Ability to manage different (and sometimes conflicting) priorities
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Detail-oriented but able to also see big picture strategy
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Clear communicator
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Ask questions to come to resolution on open items during field action execution
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Strong quality system/procedural knowledge
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Comfortable managing relationships at all levels of the organization (individual contributor, manager, director, DVP)
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Interface with regulators and respond to regulator questions (FDA, notified body, competent authority)
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Flexibility on work assignments when priorities change
Preferred
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10 years of experience in a quality functional role.
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5 years of proven leadership skills, including experience setting goals, providing positive and constructive feedback and improving business results.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
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Training and career development, with onboarding programs for new employees and tuition assistance
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Financial security through competitive compensation, incentives and retirement plans
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Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
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Paid time off
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401(k) retirement savings with a generous company match
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The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.