For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose 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 than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Our location in Pleasanton or 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

• Plan, lead, execute and close reportable field actions as the field action coordinator
• 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.
• Provide influential leadership with local and International sites to drive execution of field actions
• Represent Global Strategic Compliance in support of cross-functional divisional projects
• 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
• Maintain effective quality metrics related to Health Hazard Evaluations (HHEs) and field actions and propose activities to resolve decreases in performance
• Sets goals which align to department plans and manages the execution of goals through coaching and mentoring
• Maintains a safe and professional work environment

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor’s Degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
• At least 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
• Has a history of completing successful projects and driving positive compliance outcomes.

Preferred

• 10 years of experience in a quality functional role.
• 5 years of proven leadership skills, including experience setting goals, providing positive and constructive feedback and improving business results.
• 5 years of Project Management experience
• Experience in the Healthcare industry.
• Ability to lead cross functional, often international teams made up of stakeholders with different, sometimes conflicting, priorities, questions, motives and concerns
• Ability to present in front of senior levels of the organization
• Ability to manage different (and sometimes conflicting) priorities
• Detail-oriented but able to also see big picture strategy
• Clear communicator
• Ask questions to come to resolution on open items during field action execution
• Strong quality system/procedural knowledge
• Comfortable managing relationships at all levels of the organization (individual contributor, manager, director, DVP)
• Interface with regulators and respond to regulator questions (FDA, notified body, competent authority)
• Flexibility on work assignments when priorities change

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development , with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs. 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.
• Paid time off
• 401(k) retirement savings with a generous company match
• 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.

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