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Fda Contractor Jobs in Baltimore, MD (NOW HIRING)

micro1 AI

Compliance Officers

Baltimore, MD · Remote

$50 - $70/hr

Contractor Location: Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

Cni

Project Manager III

Silver Spring, MD

S. Food and Drug Administration (FDA), specifically for the Office of Food Policy and Response ... As a federal contractor, CNI is a drug-free workplace and adheres to the Federal Controlled ...

Ampcus

Spec, Utilization Management

Baltimore, MD · On-site

FDA, National Comprehensive Cancer Network, Clinical trials.Gov, National Institute of Health, etc ... Collaborates with medical directors, sales and marketing, contracting, provider and member services ...

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All JobsFda Contractor JobsFda Contractor Jobs in Baltimore, MD

Fda Contractor information

See Baltimore, MD salary details

$29.8K

$60.4K

$87.9K

How much do fda contractor jobs pay per year?

As of Aug 10, 2026, the average yearly pay for fda contractor in Baltimore, MD is $60,443.00, according to ZipRecruiter salary data. Most workers in this role earn between $48,200.00 and $69,600.00 per year, depending on experience, location, and employer.

What is an FDA contractor?

An FDA contractor is an individual or company that provides goods or services to the U.S. Food and Drug Administration (FDA) under a formal agreement or contract. These contractors may work in a wide range of areas including research, information technology, regulatory consulting, laboratory services, or facility maintenance. FDA contractors are not direct employees of the FDA but play a crucial role in supporting the agency’s mission to protect public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. Their work is often governed by strict regulations and requires compliance with federal standards. Contractors are selected through a competitive procurement process to ensure quality and value.

What are some common challenges faced by FDA contractors when working with cross-functional teams?

FDA Contractors often collaborate with diverse teams, including regulatory, quality assurance, and clinical staff. One common challenge is aligning different priorities and communication styles while ensuring compliance with regulatory standards and tight project deadlines. Success in this role requires strong organizational skills, adaptability, and proactive communication to keep projects moving smoothly and maintain regulatory integrity. Building rapport and understanding the unique needs of each department can help FDA Contractors effectively bridge gaps and facilitate teamwork.

What is the difference between Fda Contractor vs Fda Auditor?

AspectFda ContractorFda Auditor
Required CredentialsTypically requires knowledge of FDA regulations, compliance, and industry standards; certifications like RAC or CQA are commonRequires similar credentials, often with additional auditing certifications such as CQA or ISO auditor training
Work EnvironmentWorks on projects for FDA-regulated companies, often in labs, manufacturing sites, or officesConducts inspections and audits at facilities, often traveling to various sites
Employer & Industry UsageHired by pharmaceutical, biotech, or medical device companies as external consultantsEmployed by regulatory agencies or contracted to perform compliance audits for FDA oversight

In summary, Fda Contractors focus on supporting companies with compliance projects, while Fda Auditors primarily evaluate and verify adherence to FDA regulations through inspections and audits. Both roles require similar certifications and industry knowledge but differ in their primary functions and work settings.

What are the key skills and qualifications needed to thrive as an FDA contractor?

To thrive as an FDA Contractor, you need expertise in regulatory compliance, scientific analysis, and project management, often supported by a degree in life sciences or a related field. Familiarity with FDA regulations, electronic submission systems, and specialized software like eCTD or data analysis tools is typically required. Attention to detail, strong communication skills, and adaptability help contractors excel in collaborative and deadline-driven environments. These skills ensure accurate, timely submissions and effective support for FDA regulatory processes.
What job categories do people searching Fda Contractor jobs in Baltimore, MD look for? The top searched job categories for Fda Contractor jobs in Baltimore, MD are:
What cities near Baltimore, MD are hiring for Fda Contractor jobs? Cities near Baltimore, MD with the most Fda Contractor job openings:
Fda Contractor jobs near you
Infographic showing various Fda Contractor job openings in Baltimore, MD as of August 2026, with employment types broken down into 70% Full Time, 9% Part Time, and 21% Contract. Highlights an 88% Physical, 1% Hybrid, and 11% Remote job distribution, with an average salary of $60,443 per year, or $29.1 per hour.

Compliance Officers

micro1 AI

Baltimore, MD • Remote

$50 - $70/hr

Part-time

Posted 6 days ago

Job description

Role Title: Regulatory Affairs Specialist


Role Type: Contractor


Location: Remote


micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.


Scope of Work

  1. Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
  2. Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.
  3. Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.
  4. Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
  5. Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
  6. Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.


Preferred Qualifications

  1. 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.
  2. Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
  3. Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada).
  4. Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.
  5. Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.
  6. Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.
  7. Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).

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