ABBOTT LABORATORIES Regulatory Affair Project Manager (Principal RA Specialist) Salary in the United States

How much does a Regulatory Affair Project Manager (Principal RA Specialist) make at companies like ABBOTT LABORATORIES in the United States? The average salary for Regulatory Affair Project Manager (Principal RA Specialist) at companies like ABBOTT LABORATORIES in the United States is $146,742 as of November 27, 2023, but the range typically falls between $130,871 and $162,612. 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 Affair Project Manager (Principal RA 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.

This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of programs.

Job Duties:

  • Develops sound global regulatory strategies for new and modified medical devices.
  • Prepares robust regulatory applications to achieve departmental and organizational objectives.
  • Creates, reviews and approves engineering changes.
  • Provides leadership and guidance (including training) to other members of the RA staff.
  • Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations. 
  • Provides Regulatory leadership to development teams:
    • Provides global strategic input (including all feasible alternatives and associated risks).
    • Drives cross functional alignment with issues that could have Regulatory ramifications.
  • Independently interacts and builds partnerships with competent authorities (FDA, and other regulatory agencies).
  • Builds strategic partnerships to further departmental and organizational objectives.
  • Reviews of product and manufacturing changes for compliance with applicable regulations (Change Control).
  • Reviews protocols and reports to support regulatory submissions.
  • Assesses proposed regulations and communicates new requirements to the organization.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Assists with audits and inspections, if required.


  • BA or BS degree (degree in a technical discipline highly preferred).
  • Minimum 6 years regulatory experience; 8 years preferred.
  • Experience with 510(k) applications, IDEs, PMA or PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • 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.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 5%, including internationally.
  • Ability to maintain regular and predictable attendance.
  • Ability to work independently with no oversight.
  • Ability to identify and solve problems in a strategic manner.
  • Ability to manage complex projects.
  • Ability to be proactive and not reactive, to anticipate changing business and regulatory environments.
Check out Regulatory Affair Project Manager (Principal RA Specialist) jobs in Ashburn, Virginia

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$130,871 Low Average $146,742 High $162,612

Understand the total compensation opportunity for Regulatory Affair Project Manager (Principal RA 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 Affair Project Manager (Principal RA Specialist) in the United States, which includes base, and annual incentives can vary anywhere from $130,871 to $162,612 with an average total cash compensation of $146,742. 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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