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Abbott Sr Regulatory Compliance Audit in Temecula, California

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 113,000 colleagues serve people in more than 160 countries.

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 113,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

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 113,000 colleagues serve people in more than 160 countries.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our remote position has an opening for a Sr. Specialist, Regulatory Affairs.

WHAT YOU'LL DO

The Regulatory Compliance Auditor performs assessments of the Division quality systems worldwide to determine whether the quality system is in compliance with the established requirements and to evaluate its effectiveness.

Core Job Responsibilities:

  • Audits areas of the Division quality system, such as development and manufacturing, as assigned.

  • Creates audit checklists based on assigned area, applicable regulations, and pertinent Division quality system/procedural requirements, and obtains approval from Lead Auditor as appropriate.

  • Evaluates the adequacy and compliance of systems, operations, and practices against regulations and company documentation.

  • Formulates and documents nonconformity and obtains concurrence with responsible management.

  • Tracks issues through to closure including reviewing the corrective action taken.

  • Develops an audit plan including scope and objective and obtains management approval.

  • Provides work direction to audit team.

  • Communicates final results of audits to responsible management during formal management debriefs.

  • Writes reports of audit results, obtains approval, and publishes results to responsible management.

  • Oversees follow-up of corrective actions and audit closure, including escalating overdue items as necessary.

  • Serves as escort to inspectors or assessors from regulatory agencies or notified bodies.

  • Provides input to Regulatory Compliance Manager on audit staff performance.

  • As requested, coordinates product actions (for example recalls) with manufacturing units and affiliates.

  • As requested, communicates product actions and subsequent updates to regulatory bodies.

  • Serves as quality system expert resource to management and to other business units as requested.

  • Presents results of audits to senior management such as during periodic quality system reviews.

  • Serves as point-of-contact for regulatory agency inspections or assessments.

  • Works with Regulatory Compliance Manager to develop the annual audit schedule, assignments, and budgetary impact.

  • Provides input to Regulatory Compliance Manager regarding Lead Auditor performance.

EDUCATION AND EXPERIENCE YOU'LL BRING

  • Bachelor's degree in a related field.

  • Master's degree preferred.

  • Or an equivalent amount of education and work experience.

  • Minimum of 6 years experience with a strong understanding of specified functional area.

  • Solid understanding and application of business concepts, procedures and practices.

  • Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

  • Has a sound knowledge of a variety of alternatives and their impact on their business unit.

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 corpjat@abbott.com

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