ABBOTT LABORATORIES Quality Systems, Principal Regulatory Compliance Specialist Salary in the United States

How much does a Quality Systems, Principal Regulatory Compliance Specialist make at companies like ABBOTT LABORATORIES in the United States? The average salary for Quality Systems, Principal Regulatory Compliance Specialist at companies like ABBOTT LABORATORIES in the United States is $97,668 as of June 27, 2024, but the range typically falls between $86,842 and $108,494. Salary ranges can vary widely depending on many important factors, including education, certifications, additional skills, the number of years you have spent in your profession. With more online, real-time compensation data than any other website, Salary.com helps you determine your exact pay target.  View the Cost of Living in Major Cities

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What does a Quality Systems, Principal Regulatory Compliance Specialist do at companies like ABBOTT LABORATORIES?

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 103,000 colleagues serve people in more than 160 countries.

The Principal Regulatory Compliance Specialist position provides compliance oversight and guidance for quality systems, quality subsystems and/or key processes. Incumbent manages compliance activities and assessing impact and/or implementation of new or changing regulations to quality systems for Division, manufacturing sites and/or affiliates. Facilitate and coordinate inspection/audit readiness activities and communicates progress updates and opportunities for improvements to management as applicable and provides compliance direction for audit action plans.

Responsibilities:

  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Lead projects to support Divisional scope; multi-site quality system projects with cross-functional and represent own team while on cross-functional project teams with other functional leaders.
  • Supports achieving Division goals and strategic initiatives.
  • Communicates confidently and effectively with management, peers and key stakeholders, ensuring successful compliance status of the Division, manufacturing sites and/or affiliates.
  • Interprets regulations and requirements and supports implementation of program and procedures to meet requirements worldwide.

The above statements are intended to describe the general nature and level of work being performed, other duties may be performed as assigned.

Position Accountability / Scope

The incumbent will report to the Manager, Quality Systems Regulatory Compliance. It is expected that this individual will interact frequently with Division management and therefore requires a high level of competence, confidence and credibility.

General:

  • Develops local strategy which is aligned with the business strategy and implements related tactical activities.
  •  Translates strategic needs of the division into executable long-range programs and projects.
  • Provide solutions to a wide range of difficult problems.
  • Solutions are compliant; innovative; thorough; practical and consistent with organizational objectives.
  • Leads projects with cross-functional broader scope. Represents team on cross-functional projects with other functional leaders.
  • Directly influences project direction and scope.
  • Interacts effectively with employees; manager; and cross-functional peers.
  • Excels in effective and positive communications.
  • Contributes functional skills and expertise broadly.
  • Scope includes one or more QA functions with general knowledge of other related disciplines.
  • Provides guidance and trains other Professionals and Technicians.
  • May provide oversight to one or more QA professionals and/or contractors.

Quality System Compliance

  • Demonstrates good; general understanding of the standards and regulatory bodies that regulate our industry.
  • Ensures compliance to Division and Corporate policies and procedures.
  • Implements and maintains effectiveness of ADD's Quality System; including the Subsystems and Key processes that govern the area by identifying compliance risks.

Risk Management:

  • Leads ADD in determining the changes; improvements; and investments needed to support the Risk Management process in the Quality System and business driven objectives.
  • Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.

Documentation & Change Control:

  • Demonstrates a strong working knowledge of the potential global impact of changes including safety and efficacy.
  • Negotiates complex changes. Identifies key processes that may be impacted as a result of the change.

Education:

Apprenticeship or Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.

Experience:

At least 8 years work experience in Quality or related filed experience; Less experience may be appropriate with advanced degree.

Has experience in the health care industry.

Has a history of completing successful cross-functional projects and driving positive compliance outcomes.

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$86,842 Low Average $97,668 High $108,494

Understand the total compensation opportunity for Quality Systems, Principal Regulatory Compliance Specialist at companies like ABBOTT LABORATORIES, base salary plus other pay elements

Average Total Cash Compensation

Includes base and annual incentives

$86,842
$108,494
$97,668
The chart shows total cash compensation for the ABBOTT LABORATORIES Quality Systems, Principal Regulatory Compliance Specialist in the United States, which includes base, and annual incentives can vary anywhere from $86,842 to $108,494 with an average total cash compensation of $97,668. Total compensation includes the value of any benefits received in addition to your salary and some of the benefits that are most commonly provided within a total compensation package including bonuses, commissions, paid time off, and Insurance. The total cash compensation may get paid differently by industry, location, and other factors.
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