ABBOTT LABORATORIES Regulatory Operations Specialist Salary in the United States

How much does a Regulatory Operations Specialist make at companies like ABBOTT LABORATORIES in the United States? The average salary for Regulatory Operations Specialist at companies like ABBOTT LABORATORIES in the United States is $76,157 as of September 25, 2023, but the range typically falls between $64,317 and $87,996. 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, helps you determine your exact pay target.  View the Cost of Living in Major Cities2


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What does a Regulatory Operations 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.

As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and exercise influence generally at the middle management level.  The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.


  • Provide regulatory input to product lifecycle planning. Assist in SOP development and review.
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
  • Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
  • Determine trade issues to anticipate regulatory obstacles. Participate in risk benefit analysis for regulatory compliance.
  • Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
  • Assist in preparation and review of regulatory submission to authorities.
  • Maintain annual licenses, registrations, listings and patent information.
  • Assist compliance with product post marketing approval requirements. Assist in the review of advertising and promotional items.
  • Assess external communications relative to regulations. Review regulatory aspects of contracts.
  • Assist with label development and review for compliance before release.
  • Submit and review change controls to determine the level of change and consequent submission requirements.
  • Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product associated events are reported to regulatory agencies.
  • Provide regulatory input for product recalls and recall communications.
  • Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments. May lead a departmental project team.
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Participates in determining goals and objectives for projects.
  • Influences middle management on technical or business solutions.
  • May interact with vendors.
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.


Bachelors Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred and/or an equivalent combination of education and work experience.  Masters Degree -Preferred

  • Minimum 2 years-This position does not require previous regulatory experience. 2-3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel;  Principles and requirements of applicable product laws;  Submission/registration types and requirements;  GxPs (GCPs, GLPs, GMPs);  Principles and requirements of promotion, advertising and labeling;  Domestic and international regulatory guidelines, policies and regulations;  Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position. 
  • Communicate effectively verbally and in writing.  Communicate with diverse audiences and personnel.  Write and edit technical documents.
  • Work with cross-functional teams.  Work with people from various disciplines and cultures.
  • Write and edit technical documents. 
  • Negotiate internally. 
  • Pay strong attention to detail.
  •  Manage projects. Create project plans and timelines.
  • Think analytically and critically.
  • Organize and track complex information.
  • Exercise 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 the business.
  • Apply business and regulatory ethical standards.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)  

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$64,317 Low Average $76,157 High $87,996

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

Average Total Cash Compensation

Includes base and annual incentives

The chart shows total cash compensation for the ABBOTT LABORATORIES Regulatory Operations Specialist in the United States, which includes base, and annual incentives can vary anywhere from $64,317 to $87,996 with an average total cash compensation of $76,157. 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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