ABBOTT LABORATORIES Manager Regulatory Affairs - Pleasanton Salary in the United States

How much does a Manager Regulatory Affairs - Pleasanton make at companies like ABBOTT LABORATORIES in the United States? The average salary for Manager Regulatory Affairs - Pleasanton at companies like ABBOTT LABORATORIES in the United States is $140,447 as of October 25, 2023, but the range typically falls between $119,282 and $161,612. 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, Salary.com helps you determine your exact pay target.  View the Cost of Living in Major Cities2

About ABBOTT LABORATORIES

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What does a Manager Regulatory Affairs - Pleasanton 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 Regulatory Operations Manager will establish and work with their group to: Provide infrastructure to the business unit Regulatory Affairs department; coordinating with global regulatory for cross-business activities and trans-franchise leasers for business unit activities Ensure the active, systematic collection and interpretation of data or other information about a marketed device is tracked and reported as needed.  Responsible for data/metrics on product approval status and predictability for business unit Regulatory Affairs Ensure coordination and interaction with international affiliates to ensure surveillance enabling compliance to applicable global regulations and maintenance of product approvals Monitor scheduling of post market activities to ensure maintenance of product approvals.  Coordinate and prepare responses to inquires in a professional and timely manner Manage audits and CAPA activities for the business unit Regulatory function

Main Responsibilities

  • Supports all business segment initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Recruits, coaches and develops organizational talent.
  • Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • Creates an entrepreneurial environment.
  • Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
  • May supervise non-exempt employees.
  • Keeps the organization's vision and values at the forefront of decision making and action.
  • Demonstrates effective change leadership.
  • Builds strategic partnerships to further departmental and organizational objectives.
  • Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
  • Monitors department compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
  • Makes decisions regarding work processes or operational plans and schedules to achieve department objectives.
  • Develops, monitors and appropriately adjusts the annual budget for department cost center(s).
  • Provides appropriate level of cross-functional and customer-oriented communications regarding the status of department and quality system operation, as well as product performance.
  • Performs other related duties and responsibilities, on occasion, as assigned such as reviews product and manufacturing changes for compliance with applicable regulations (Change Control), prepare submissions…etc.

Influence/Leadership

  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel.
  • May lead a project team.
  • Participates in determining goals and objectives for projects.
  • Influences middle management on technical or business solutions.
  • May interact with vendors.

Planning/Organization

  • Plans and organizes non-routine tasks w/approval.
  • Initiates or maintains work schedule.
  • Establishes priorities of work assignments.

Decision Making/Impact

  • 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 program delays and considerable expenditure of resources.

Qualifications

  • Bachelor's degree plus 7+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience.
  • Advanced degree preferred.  

Technical/Business Knowledge - Job Skills

  • Broad knowledge of post market surveillance regulations, practices, and procedures.
  • Strong understanding of business unit function and cross group dependencies/relationships.
  • Will perform this job in a quality system environment.
  • Failure to adequately perform tasks can result in noncompliance with governmental regulations.

Cognitive Skills:

  • 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.
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$119,282 Low Average $140,447 High $161,612

Understand the total compensation opportunity for Manager Regulatory Affairs - Pleasanton at companies like ABBOTT LABORATORIES, base salary plus other pay elements

Average Total Cash Compensation

Includes base and annual incentives

$119,282
$161,612
$140,447
The chart shows total cash compensation for the ABBOTT LABORATORIES Manager Regulatory Affairs - Pleasanton in the United States, which includes base, and annual incentives can vary anywhere from $119,282 to $161,612 with an average total cash compensation of $140,447. 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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