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Regulatory Labeling Jobs (NOW HIRING)

Food and Drug Administration (FDA) regulations, company policies and operating procedures, and ... Tracks and maintains labeling documents using process tools for revision control. * Reviews ...

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Regulatory Labeling information

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$12

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$95

How much do regulatory labeling jobs pay per hour?

As of Jul 13, 2026, the average hourly pay for regulatory labeling in the United States is $30.53, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $39.18 per hour, depending on experience, location, and employer.

What is the difference between Regulatory Labeling vs Regulatory Documentation?

AspectRegulatory LabelingRegulatory Documentation
PurposeEnsures product labels meet regulatory standards and communicate necessary information to consumers and authorities.Prepares comprehensive reports, submissions, and records required for regulatory approval and compliance.
Work EnvironmentPrimarily office-based, collaborating with marketing, legal, and regulatory teams.Office and laboratory settings, often involving detailed technical writing and data compilation.
Required CredentialsTypically requires a degree in life sciences, regulatory affairs, or related fields; certifications like RAC are common.Similar credentials, often with advanced degrees or certifications in regulatory affairs or quality assurance.

While both roles focus on compliance, Regulatory Labeling concentrates on product labels and packaging, ensuring they meet legal standards. Regulatory Documentation involves creating detailed reports and submissions for regulatory approval. Both roles require similar qualifications and often work together to ensure product compliance throughout the development and marketing process.

What are the key skills and qualifications needed to thrive as a Regulatory Labeling Specialist, and why are they important?

To thrive as a Regulatory Labeling Specialist, you need a strong understanding of regulatory requirements, scientific knowledge, and experience with labeling guidelines, often supported by a life sciences degree. Familiarity with regulatory submission systems (such as FDA’s SPL), document management tools, and relevant certifications like RAC are typically required. Attention to detail, effective communication, and project management skills help ensure accuracy and collaboration across teams. These competencies are critical to producing compliant, clear, and timely product labeling that meets global regulatory standards.

What are some common challenges faced in a Regulatory Labeling role, and how can they be managed?

Professionals in Regulatory Labeling often encounter challenges such as keeping up with constantly changing global regulations, coordinating input from multiple departments, and ensuring labeling accuracy across different markets. Managing these challenges typically involves maintaining strong communication with regulatory affairs, legal, and product development teams, as well as staying updated through regulatory databases and ongoing training. Leveraging project management tools and establishing clear review processes can also help ensure labeling compliance and timely submissions.

What is a regulatory labeling specialist?

A regulatory labeling specialist is a professional responsible for developing, reviewing, and maintaining product labels to ensure compliance with industry regulations and standards. They often work with regulatory agencies, use labeling software, and stay updated on legal requirements to ensure accurate and compliant product information.

What is regulatory labeling?

Regulatory labeling refers to the process of creating, reviewing, and maintaining product labels to ensure they comply with all relevant laws and regulations set by government authorities. This is especially important in industries like pharmaceuticals, food, and chemicals, where product labels must accurately reflect usage instructions, safety information, and legal requirements. Regulatory labeling professionals work closely with regulatory agencies and internal teams to make sure that all product information is truthful, clear, and up to date. Failure to comply with labeling regulations can result in fines, product recalls, or legal action.

What is regulatory labelling?

Regulatory labeling involves creating and maintaining product labels that comply with government regulations and industry standards. It ensures that product information such as safety warnings, ingredients, and usage instructions meet legal requirements, often requiring attention to detail and knowledge of relevant regulations. Regulatory labelers may work with documentation tools and certification processes to ensure compliance.

Which is better, RA or QA?

Regulatory Affairs (RA) and Quality Assurance (QA) are distinct roles in the compliance and quality management of products. RA focuses on ensuring products meet regulatory requirements and preparing documentation for approval, while QA emphasizes maintaining product quality through testing and process controls. Both roles are essential, and their importance depends on the company's priorities and product lifecycle stage.

What is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are typically senior executive positions such as Vice President or Director of Regulatory Affairs, which can earn six-figure salaries. These roles often require extensive experience, advanced certifications, and leadership skills in managing compliance strategies across industries like pharmaceuticals and medical devices.
More about Regulatory Labeling jobs
What cities are hiring for Regulatory Labeling jobs? Cities with the most Regulatory Labeling job openings:
What are the most commonly searched types of Regulatory Labeling jobs? The most popular types of Regulatory Labeling jobs are:
What states have the most Regulatory Labeling jobs? States with the most job openings for Regulatory Labeling jobs include:
Infographic showing various Regulatory Labeling job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 71% Full Time, 23% Part Time, 1% Temporary, 3% Contract, and 1% Nights. Highlights an 97% Physical, and 3% Remote job distribution, with an average salary of $63,493 per year, or $30.5 per hour.
Regulatory Affairs Associate

Regulatory Affairs Associate

Intellectt INC

Santa Clara, CA • On-site

Contractor

Posted 22 days ago


Job description

Job Title: Regulatory Affairs Associate

Location: Santa Clara, CA

Duration: 12 Months

Schedule: 8:00 AM – 5:00 PM

Position Overview

The Regulatory Affairs Associate will be responsible for supporting regulatory strategy, submissions, and compliance activities for Class III implantable medical devices. This role requires strong expertise in FDA regulatory pathways, labeling requirements, and PMA supplement submissions. The candidate will work cross-functionally with engineering, quality, and manufacturing teams to ensure regulatory compliance throughout the product lifecycle.

Key Responsibilities

  • Author, review, and submit PMA supplements, including:
    • 30-Day Notices
    • Real-Time Reviews
    • 180-Day Supplements
    • Annual Reports
  • Manage and execute regulatory labeling activities, including addendum and supplemental labeling updates
  • Review and approve:
    • Engineering study protocols and reports
    • Validation study protocols and reports
    • Manufacturing changes for Class III implantable devices
  • Ensure compliance with FDA PMA guidance documents and CFR regulations
  • Serve as a liaison for regulatory authority interactions, including submission handling and follow-ups
  • Collaborate with cross-functional teams to support product development and change management
  • Provide regulatory guidance and may lead or direct the work of junior team members

Required Qualifications

  • Minimum 5+ years of experience in Regulatory Affairs
  • Strong experience with Class III implantable medical devices
  • Proven track record of successful PMA supplement authoring, submission, and approvals
  • Hands-on experience with regulatory labeling (addendum, supplemental, and change execution)
  • Solid understanding of FDA regulations and medical device quality systems
  • Ability to manage multiple projects with a high degree of autonomy and judgment

Preferred Skills

  • Experience working in a highly regulated medical device environment
  • Strong analytical, documentation, and communication skills
  • Ability to work independently and lead cross-functional initiatives