Senior Auditor Regulatory Compliance Specialist

2 days ago

Columbus, Ohio, United States Abbott Laboratories company Full time

About Abbott

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.

Join Our Team

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

  • Competitive Compensation and incentives
  • Training and Career Development with onboarding programs for new employees and tuition assistance
  • Financial Security through retirement plans and health care and well-being programs
  • Robust 401(k) Retirement Savings with a generous company match
  • Tuition Reimbursement and the Freedom 2 Save student debt program
  • A Company Recognized as a Great Place to Work in dozens of countries around the world

About the Role

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.

Main 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 Management 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 Management to develop the annual audit schedule, assignments, and budgetary impact.

Provides input to Regulatory Compliance Management regarding Lead Auditor performance.

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