ABBOTT LABORATORIES Specialist II, Regulatory Affairs Salary in the United States

How much does a Specialist II, Regulatory Affairs make at companies like ABBOTT LABORATORIES in the United States? The average salary for Specialist II, Regulatory Affairs at companies like ABBOTT LABORATORIES in the United States is $98,918 as of January 26, 2024, but the range typically falls between $84,915 and $112,921. 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

Browse other Companies in the MFG Durable Industry

View abbott laboratories Salary

What does a Specialist II, Regulatory Affairs 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 performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.  Supports necessary regulatory activities required for product market entry

  • Prepares robust regulatory applications (either for FDA, and/or for international regulatory agencies) to achieve departmental and organizational objectives.
  • Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
  • Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.  Provides guidance and expertise.
  • Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
  • Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.  Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.   
  • May interface directly with FDA and other regulatory agencies.
  • Work with cross-functional team to support product release process.
  • Reviews protocols and reports to support regulatory submissions.
  • 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.
  • Performs other related duties and responsibilities, on occasion, as assigned

Qualification:

  • BA or BS degree; technical discipline preferred.
  • Minimum 3 years of experience, including a minimum of two years regulatory experience.
  • Experience writing with PMA and 510(k) applications.
  • Experience working with US device regulations and with EU and other international medical device regulations and submissions.
  • Experience working on project teams (new product development and/or sustaining)
  • Experience working with software as medical device and Class III is a plus.
  • 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 10%, including internationally.
  • Ability to maintain regular and predictable attendance.
Check out Specialist II, Regulatory Affairs jobs in Ashburn, Virginia

Public Affairs Specialist

Strategic Insight, Ltd. - Arlington, VA

Contract Specialist II

SiloSmashers - Arlington, VA

$84,915 Low Average $98,918 High $112,921

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

Average Total Cash Compensation

Includes base and annual incentives

$84,915
$112,921
$98,918
The chart shows total cash compensation for the ABBOTT LABORATORIES Specialist II, Regulatory Affairs in the United States, which includes base, and annual incentives can vary anywhere from $84,915 to $112,921 with an average total cash compensation of $98,918. 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.
Job Openings for ABBOTT LABORATORIES Specialist II, Regulatory Affairs
As a Contracts Specialist II , you will have a critical role performing various pre-and post ... Apply established acquisition/purchasing regulations, policies, and procedures while assisting in ...
ZipRecruiter ATS Jobs for ZipSearch/ZipAlerts - 1 day ago
As a Compliance Specialist II (Environmental) at ARETUM, you will play a vital role in ensuring compliance with environmental regulations and policies. ARETUM is known for providing cutting-edge ...
LinkedIn - 23 days ago
FedWriters - Fairfax , VA
... affairs specialists * Providing mechanisms and guidance for consistent information sharing and ... These regulations prohibit discrimination against qualified individuals based on their status as ...
ZipRecruiter ATS Jobs for ZipSearch/ZipAlerts - 7 days ago
Stafford Consulting Company, Inc. - Fairfax , VA
OR: Two (2) years of experience performing equivalent duties and having 24 semester hours of ... We are a Veterans Affairs (VA) CVE verified Service-Disabled Veteran-Owned Small Business (SDVOSB
ZipRecruiter - 10 days ago
Arrow Alliance Industries, LLC - Reston , VA
... Affairs. The specific assignment will be with the Branch of Real Property & Leasing (BRPL). The ... and zoning regulations, parking restrictions and economic factors affecting the market
ZipRecruiter ATS Jobs for ZipSearch/ZipAlerts - 13 days ago
Four Inc. - Fort Belvoir , VA
The Outreach and Communications Specialist also assumes the role as the client's Public Affairs ... * 2-3 years of experience in marketing, communications, or customer service environment
ZipRecruiter ATS Jobs for ZipSearch/ZipAlerts - 23 days ago

Are you an HR manager or compensation specialist?

Salary.com's CompAnalyst platform offers:

  • Detailed skills and competency reports for specific positions
  • Job and employee pricing reports
  • Compensation data tools, salary structures, surveys and benchmarks.
Learn about CompAnalyst