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Regulatory Affairs Contractor Jobs (NOW HIRING)

Nurix

Director, Regulatory Affairs

Brisbane, CA

$180K - $238K/yr

Director, Regulatory Affairs (Strategy, Immunology and Inflammation) Nurix Therapeutics is a ... Manages consultants and contractors as needed Requirements * Bachelor's degree in life-sciences or ...

Nurix

Director, Regulatory Affairs

Brisbane, CA · On-site

$180K - $238K/yr

Director, Regulatory Affairs (Strategy, Immunology and Inflammation) Nurix Therapeutics is a ... Manages consultants and contractors as needed Requirements * Bachelor's degree in life-sciences or ...

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How much do regulatory affairs contractor jobs pay per hour?

As of Jul 27, 2026, the average hourly pay for regulatory affairs contractor in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

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

To thrive as a Regulatory Affairs Contractor, you need a solid understanding of regulatory guidelines, submission processes, and compliance requirements, often supported by a degree in life sciences or a related field. Familiarity with electronic submission systems (such as eCTD), regulatory databases, and certifications like RAC are highly valued. Strong attention to detail, effective communication, and project management skills help you navigate complex regulations and coordinate across departments. These skills ensure timely approvals, minimize compliance risks, and support successful product market entry.

What are some typical challenges faced by Regulatory Affairs Contractors when managing submissions across multiple regions?

Regulatory Affairs Contractors often encounter challenges related to varying regulatory requirements, documentation standards, and submission timelines across different countries or regions. Navigating these complexities requires strong attention to detail, up-to-date knowledge of global regulations, and effective communication with cross-functional teams. Contractors must frequently coordinate with local affiliates, adapt to shifting regulatory landscapes, and ensure timely, compliant submissions—making adaptability and organizational skills essential for success in this role.

What is the difference between Regulatory Affairs Contractor vs Regulatory Affairs Specialist?

AspectRegulatory Affairs ContractorRegulatory Affairs Specialist
CredentialsTypically requires a degree in life sciences or related field; certifications like RAC are commonSame as contractor; often holds similar certifications and degrees
Work EnvironmentContract-based, project-specific, often freelance or temporary rolesFull-time, permanent roles within companies or organizations
Employer & Industry UsageUsed by companies seeking flexible regulatory support, especially during product launches or auditsEmployed by companies to ensure ongoing regulatory compliance and submissions

While both roles require similar credentials and work within the same industry, a Regulatory Affairs Contractor typically works on a temporary, project basis, providing specialized expertise as needed. In contrast, a Regulatory Affairs Specialist is a full-time employee responsible for ongoing regulatory activities within an organization.

What are Regulatory Affairs Contractors?

Regulatory Affairs Contractors are professionals hired on a temporary or project basis to support organizations in managing regulatory compliance and submissions. They help ensure that products, such as pharmaceuticals, medical devices, or food items, meet all governmental regulations and industry standards. These contractors often prepare documentation, interact with regulatory agencies, and provide strategic advice on regulatory requirements. Their expertise is especially valuable during product development, market entry, or when navigating changes in regulations.
More about Regulatory Affairs Contractor jobs
What cities are hiring for Regulatory Affairs Contractor jobs? Cities with the most Regulatory Affairs Contractor job openings:
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What job categories do people searching Regulatory Affairs Contractor jobs look for? The top searched job categories for Regulatory Affairs Contractor jobs are:
Regulatory Affairs Contractor jobs near you
Infographic showing various Regulatory Affairs Contractor job openings in the United States as of July 2026, with employment types broken down into 72% Full Time, 25% Part Time, 1% Temporary, and 2% Contract. Highlights an 75% Physical, 2% Hybrid, and 23% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Remote Regulatory Affairs contractor

Globalchannelmanagement

Atlanta, GA • Remote

$99 - $100/hr

Full-time

Posted 14 hours ago

Job description

Remote Regulatory Affairs contractor requires:

  • Bachelor's degree in engineering, life sciences, regulatory affairs, legal or a related field
  • 5-10 years+ of global medical device regulatory experience
  • Proven experience preparing, writing and submitting FDA 510k submissions (end to end)
  • Experience with ophthalmic devices, capital equipment, diagnostic devices, software in medical devices, cybersecurity
  • Strong working knowledge of:
    • FDA regulations (21 Parts 807, 820)
    • FDA guidance documents and eStar requirements
    • Experience with Canadian regulations, EU MDR (2017/745) including Class lla, Tech docs Annex ll/lll
  • Demonstrated ability to work independently as a contractor in a fast-paced environment
  • Experience filing medical device submissions in China and other countries
  • Experience with audiology devices
  • Experience with artificial-intelligence enabled devices
  • Strong technical writing and documentation skills
  • Ability to translate complex technical information into regulatory submissions
  • Detail-oriented with strong organization skills
  • Effective communicator across technical and non-technical stakeholders
  • Ability to manage multiple deliverables and timelines

DUTIES:

  • FDA 510(k) submission
  • Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance
  • Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents)
  • Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format,
  • Lead submission lifecycle activities, including:
    • Acceptance Review support (RTA readiness)
    • Substantive Review coordination
    • Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications
    • Updating submission content and modules as required
  • Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process.
  • Provide regulatory leadership through FDA clearance.
  • EU MDR Technical Documentation Support
  • Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements.
  • Perform critical review and gap analysis of EU MDR technical file
  • Provide targeted recommendations to ensure audit-readiness and Notified Body acceptance
  • Lead or support submission to obtain CE Mark
  • Health Canada submission
  • Global Regulatory Strategy and Advisory