ABBOTT LABORATORIES Regulatory Affairs Specialist - Medical Device Salary in the United States

How much does a Regulatory Affairs Specialist - Medical Device make at companies like ABBOTT LABORATORIES in the United States? The average salary for Regulatory Affairs Specialist - Medical Device at companies like ABBOTT LABORATORIES in the United States is $89,810 as of April 24, 2024, but the range typically falls between $77,299 and $102,321. 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 Regulatory Affairs Specialist - Medical Device 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.

Position Overview

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.

Main Responsibilities

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Core job responsibilities for this function may include:
  • Strategic Planning
  • Assist in SOP development and review.
  • Provide regulatory input to product lifecycle planning.
  • 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.
  • Determine and communicate submission and approval requirements.
  • Participate in risk-benefit analysis for regulatory compliance Premarket:
  • 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 Post-market:
  • Maintain annual licenses, registrations, listings and patent information.
  • Assist compliance with product post-marketing approval requirements.
  • 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.
  • Ensure product safety issues and product-associated events are reported to regulatory agencies.
  • Provide regulatory input for product recalls and recall communications
  • Medical writing (e.g. technical files)
  • Labeling
  • Controlled substances
  • Restricted substances (e.g. REACH)
  • Compendial / standards
  • Import / export
  • Country specific regulatory support.

Preferred Experience, Education, etc.:

  • Regulatory work experience from medical device industry (e.g. IVD, diagnostics, or similar). Will also consider experience from pharmaceutical industry.
  • Experience or strong working knowledge of ISO 13485, 510k, or similar.

Required Qualifications

  • Bachelor's Degree (or equivalent); Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)  

  • 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. Note: Higher education may compensate for years of experience.

Background / Skills / Knowledge Regulatory Knowledge of (as applicable):

· 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 labeling

· Domestic and international regulatory guidelines, policies and regulations

Communication Skills or Ability to:

· 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 Cognitive Skills or Ability to:

· 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

· Apply business and regulatory ethical standards

Check out Regulatory Affairs Specialist - Medical Device jobs in Ashburn, Virginia

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Rivanna Medical, Inc. - Charlottesville, VA

$77,299 Low Average $89,810 High $102,321

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

Average Total Cash Compensation

Includes base and annual incentives

$77,299
$102,321
$89,810
The chart shows total cash compensation for the ABBOTT LABORATORIES Regulatory Affairs Specialist - Medical Device in the United States, which includes base, and annual incentives can vary anywhere from $77,299 to $102,321 with an average total cash compensation of $89,810. 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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