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Remote Fda Compliance Jobs (NOW HIRING)

JenaValve

Specialist, Clinical Compliance

Irvine, CA · On-site +1

$80K - $90K/yr

Remote - Home Office Summary: Reporting to the Senior Manager, Clinical Compliance, the Specialist ... Working knowledge of ICH E6 GCP guidelines and FDA regulations applicable to medical device ...

Apexon

Business Analyst II

Baltimore, MD · Remote

$70K - $88K/yr

The Business Analyst II will support the FDA Freedom of Information (FOI) team by assisting in the ... Remote Employment Type: W2 Only Clearance Required: Public Trust Number of Positions: 1 Required ...

Hirekeyz Inc

Scientist II

College Park, MD · Remote

... Location: (Remote but need to report to the duty station in college park, MD or other FDA ... for compliance with FDA regulations, such as that gained in analytical and investigational ...

Tempus

Senior Quality Engineer

Chicago, IL · On-site +1

Support regulatory compliance of the host system operating with Tempus Medical Device(s). * Develop ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Tempus

Senior Quality Engineer

New York, NY · On-site +1

Support regulatory compliance of the host system operating with Tempus Medical Device(s). * Develop ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Tempus

Senior Quality Engineer

Redwood City, CA · On-site +1

Support regulatory compliance of the host system operating with Tempus Medical Device(s). * Develop ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Managed Staffing

Biocompatibility Scientist

FL · Remote

$145 - $150/hr

Remote (Client HQ: Gainesville, FL - No relocation required) Job Summary We are seeking an ... Ensure compliance with applicable Quality Systems , FDA regulations, and international biological ...

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All JobsRemote Fda Compliance Jobs

Remote Fda Compliance information

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$50K

$157.5K

How much do remote fda compliance jobs pay per year?

As of Jun 9, 2026, the average yearly pay for remote fda compliance in the United States is $152,036.00, according to ZipRecruiter salary data. Most workers in this role earn between $157,000.00 and $157,000.00 per year, depending on experience, location, and employer.

What is the difference between Remote Fda Compliance vs Remote Quality Assurance Specialist?

AspectRemote Fda ComplianceRemote Quality Assurance Specialist
CertificationsFDA regulations, GMP, ISOISO, GMP, Six Sigma
Work EnvironmentRegulatory departments, compliance teamsQuality departments, manufacturing sites
Industry UsagePharmaceuticals, biotech, medical devicesManufacturing, pharmaceuticals, biotech

Remote Fda Compliance focuses on ensuring products meet FDA regulations and standards, primarily working with regulatory documentation and audits. Remote Quality Assurance Specialists concentrate on maintaining product quality through process audits and standards compliance. While both roles require knowledge of GMP and ISO, Fda Compliance emphasizes regulatory adherence, whereas Quality Assurance centers on product quality assurance processes.

What are the key skills and qualifications needed to thrive as a Remote FDA Compliance Specialist, and why are they important?

To thrive as a Remote FDA Compliance Specialist, you need a deep understanding of FDA regulations, quality systems, and industry standards, often supported by a degree in life sciences or a related field. Familiarity with compliance management software, documentation tools, and sometimes certifications like RAC (Regulatory Affairs Certification) is typically required. Attention to detail, strong organizational skills, and effective communication are critical soft skills for success in this role. These abilities ensure regulatory adherence, minimize compliance risks, and maintain the integrity of remote operations in regulated industries.

How does working remotely as an FDA Compliance specialist affect communication and collaboration with cross-functional teams?

As a remote FDA Compliance specialist, effective communication is crucial since you'll frequently collaborate with departments like quality assurance, regulatory affairs, and manufacturing. Most teams use video conferencing, project management tools, and shared documentation platforms to stay connected and ensure regulatory requirements are met. Being proactive in scheduling regular check-ins and maintaining clear documentation helps prevent misunderstandings and keeps projects on track. While remote work offers flexibility, it also requires strong organizational skills and the ability to communicate complex compliance issues clearly across virtual channels.

What is a Remote FDA Compliance specialist?

A Remote FDA Compliance specialist is a professional who ensures that a company’s products, processes, and documentation meet the regulatory requirements set by the U.S. Food and Drug Administration (FDA), all while working remotely. They monitor compliance with FDA regulations, prepare for audits, and help implement necessary changes to maintain certification. These specialists may work for pharmaceutical, biotechnology, medical device, or food companies, providing guidance and documentation support from a remote location. Their expertise helps companies avoid costly compliance issues and maintain the ability to legally market their products in the United States.
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Remote Fda Compliance jobs near you

Validation Engineer 1 as 100% Remote

Amicis Global

Sunnyvale, CA • Remote

$74/hr

Contractor

Posted 25 days ago

Job description

Title: Validation Engineer 1
Location: 100% Remote
Duration: 03 Months
Pay Rate: $60.00 - $74.00/- on W2
 
Job Description:
Summary:
This position's primary role is to work closely with the internal IT teams and cross functional departments (Business & PQ-CSV) to support computer system validation activities related to projects and change requests.
 
Roles and Responsibilities:

Top Skills:
Good understanding of CSV, CSA, FDA regulations (21 CFR Part 11 & 820), GAMP5 & GxP regulations.
Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)
• Responsible for oversight of all GxP-regulated computerized systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV), and Lifecycle procedures with Data Integrity requirements.
• Provide oversight of validation activities, lead the development and approval of validation documentation and risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessment of proposed changes to computerized systems.
• Perform and/or direct GxP computerized system validation projects in compliance with 21 CFR 820, 21 CFR Part 11, Annex 11, and Data Integrity.
• Ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and *** policies and procedures.
• Development and approval of Validation Plans, IQ, OQ Protocols, Trace Matrices, Risk Assessments and Validation Summary Reports.
• Establish validation standards, develop testing protocols, document test results and maintain records for later analysis.
• Documentation and remediation of deviations resulting from validations/qualifications.
• Provide assistance and guidance in training co-workers on validation protocols and operating procedures.
• Author/Update assigned Operating Procedures (SOPs & DOPs), Policies, validation templates to ensure compliance with Company policies and federal regulations.
• Support regulatory agency inspections/audits, as required.
• Must be familiar with cGMPs and current industry guidelines.
• Interfaces between various internal and external functional areas to assure successful integration and completion of validation activities in overall project schedules.
• Maintains awareness of regulatory requirements.
• Understanding of FDA's new guidance of CSA risk based approach validation
Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job)
• Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
• Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
• Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
• Understanding of FDA's recent guidance on transition of CSV to CSA.
• Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills.
• Ability to work on complex projects with general direction and minimal guidance.
• Ability to handle multiple projects and meet deadlines.
• Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job)
• Bachelor's degree (B.S.) in a related field or equivalent.
• 8 years hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP systems.
Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)
Hands-on experience with Microsoft Word, Excel, PowerPoint & Visio.
Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools.

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