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Compliance Specialist

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Saint Paul, MN

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At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. JOB DESCRIPTION: We are seeking an experienced, high caliber Compliance Specialist to support software product surveillance issue processing. Responsibilities include administrative and analytic support to software field issue investigations, organization of investigational materials, distribution of investigation responsibilities, and coordination of investigation and response activities. Responsibilities Include: Provide support and assistance for procedures used in the software analysis of field issues. This position will involve working closely with software subject matter experts, development engineers and product surveillance file managers. Progress investigations and other activities through the software field issue process. Maintain and track active software field investigation reports including complaint trending and summary reports. Manage returned data used for investigation processing. Enter completed investigation summaries into the complaint system. Provide feedback to improve overall performance and timeliness. Perform other related duties and responsibilities, on occasion, as assigned. Required Qualifications: Bachelor\u2019s degree or equivalent industry experience required Strong organizational and follow-up skills with attention to detail Multitasks, prioritizes and meets deadlines in timely manner. Strong verbal and written interpersonal communications Ability to work within a team and as an individual contributor in a fast-paced, changing environment Ability to leverage and\/or engage others to accomplish projects Preferred Qualifications : Competency in Excel Competency in Jira or other software issue tracking system Medical device experience preferred or experience in another regulated industry Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements a plus Knowledge of software, software applications and basic cardiology a plus

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Company Profile
We’re dedicated to fulfilling the promise of human potential, in all places, in all aspects and stages of life. We believe that health is the key to that promise. Because at our healthiest, we’re capable of achieving anything. And that’s why our pursuit of helping people achieve their best health at every life stage will never end. This is how we put that belief into practice each and every day.

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