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Remote Fda Jobs in Sutton, MA (NOW HIRING)

Qualio

Account Executive (Remote)

Boston, MA · Remote

... and FDA requirements. Qualio is ISO 27001, ISO 9001, and ISO 27701 certified, reflecting our ... The Qualio team is all-remote, and currently distributed across North America, Europe and Australia.

Vue Health

Digital Designer-Freelance/Hourly

Boston, MA · Remote

$65/hr

Freelance Digital Designer (Pharmaceutical Advertising) - 100% Remote We're looking for a Freelance ... Ensure all work aligns with FDA/regulatory guidelines and client brand standards * Manage multiple ...

Vue Health

Digital Designer-Freelance/Hourly

Boston, MA · Remote

$65 - $85/hr

Freelance Digital Designer (Pharmaceutical Advertising) - 100% Remote We're looking for a Freelance ... Ensure all work aligns with FDA/regulatory guidelines and client brand standards * Manage multiple ...

W3Global Inc.

Regulatory Associate

Boston, MA · Remote

$235K - $310K/yr

FDA Regulatory, Healthcare & Consumer Products Department: Regulatory & Compliance Locations ... Remote Patient Monitoring * Wearables * Digital Health Applications Candidates should be passionate ...

LivaNova

Regulatory & Clinical Specialist

Boston, MA · Remote

$85K - $95K/yr

FDA PMA applications, IDE Progress Reports, technical files). * Medical writing experience with US ... This is a remote role (candidates must be based in the United States) * Occasional travel may be ...

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Remote Fda information

What is a remote FDA?

A Remote FDA job typically involves working for or with the U.S. Food and Drug Administration (FDA) from a remote location. These roles can include regulatory affairs, compliance, medical writing, research, and reviewing submissions for drug and medical device approvals. Remote FDA jobs require knowledge of FDA regulations, strong analytical skills, and experience in healthcare, pharmaceuticals, or related fields. They offer flexibility while maintaining high regulatory standards and ensuring public health and safety.

What are the typical daily responsibilities of a remote FDA compliance specialist?

A Remote FDA Compliance Specialist generally reviews and updates regulatory documents, conducts virtual audits, and monitors company practices for FDA compliance. They regularly collaborate with cross-functional teams, such as quality assurance, legal, and product development, to provide guidance on regulatory requirements and respond to compliance queries. Additionally, they prepare and submit necessary reports, maintain records for inspections, and stay current on evolving regulations. This remote structure allows flexibility but also demands excellent organization, communication, and self-discipline to ensure all deadlines and compliance standards are met.

What are the key skills and qualifications needed to thrive in the remote FDA position, and why are they important?

To excel as a Remote FDA Compliance Specialist, you need in-depth knowledge of FDA regulations, quality assurance procedures, and a background in life sciences or a related field. Proficiency in using compliance management systems, electronic document management tools, and relevant certifications such as RAC (Regulatory Affairs Certification) are often required. Exceptional attention to detail, self-motivation, and strong written and verbal communication skills are vital for remote collaboration and thorough documentation. These abilities ensure regulatory adherence, minimize compliance risks, and facilitate effective remote teamwork within the pharmaceutical or medical device industry.

What jobs can I do completely remotely as a remote FDA?

A remote FDA typically refers to a Food and Drug Administration-related role that can be performed remotely, such as regulatory affairs specialists, quality assurance managers, or compliance analysts. These positions often require knowledge of regulations, strong communication skills, and familiarity with digital tools for document review and reporting, allowing work to be done entirely online. However, some roles may require occasional on-site visits or inspections depending on the specific job and employer policies.

What cities near Sutton, MA are hiring for Remote Fda jobs?

Cities near Sutton, MA with the most Remote Fda job openings:

Remote Fda jobs near you
Infographic showing various Remote Fda job openings in Sutton, MA as of June 2026, with employment types broken down into 57% Full Time, 29% Part Time, and 14% Contract. Highlights an 100% Remote job distribution.

Clinical Statistical Programming Infrastructure Engineer (SAS/AWS)- BB

TechData Service Company LLC

Boston, MA • Remote

$70 - $130/hr

Full-time

Medical, Dental, Vision, PTO

Posted 16 days ago

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Job description

Statistical Programming Infrastructure Engineer (SAS/AWS) – 2 Openings (1 Sr./1 Jr.) – Remote - BBBR

Location: Remote

Position Summary

Client is seeking 2 Statistical Programming Infrastructure Engineers (1 Senior/1 Junior) to help design, build, and maintain the company's next-generation statistical programming infrastructure within AWS. This is a unique remote role combining SAS statistical programming expertise with cloud infrastructure engineering. The successful candidate will lead the migration of on-premise statistical programming environments into a secure, scalable AWS cloud platform while establishing best practices, automation, and governance for future clinical development initiatives.

This individual will partner with Biostatistics, Statistical Programming, IT Infrastructure, Data Management, and Clinical Development teams to create an enterprise-level statistical computing environment supporting research and clinical programs.

Responsibilities

  • Design, build, and administer enterprise statistical programming infrastructure within AWS.
  • Develop and maintain SAS programming environments supporting clinical and research initiatives.
  • Configure AWS servers, storage, networking, permissions, and security for statistical computing.
  • Build standardized directory structures, environments, user access, and shared services.
  • Develop and maintain SAS Macro libraries and utility macros used across programming teams.
  • Create automated deployment and maintenance processes for SAS applications and cloud resources.
  • Support migration of existing SAS applications, programs, and datasets into AWS.
  • Collaborate with IT to establish scalable, secure cloud architecture following GxP and regulatory requirements.
  • Implement infrastructure monitoring, backup, disaster recovery, and performance optimization.
  • Develop documentation, SOPs, and technical standards for cloud-based statistical programming environments.
  • Provide technical leadership and mentorship to programming and infrastructure team members.
  • Troubleshoot complex infrastructure, SAS, and cloud-related issues.
  • Support validation activities and ensure compliance with FDA, GCP, and 21 CFR Part 11 requirements.

Required Qualifications

  • Bachelor's degree in Computer Science, Statistics, Bioinformatics, Information Systems, or related field.
  • SAS programming experience in biotechnology, pharmaceutical, or clinical research environments.
  • Strong knowledge of Base SAS, SAS Macro programming, and utility macro development.
  • Experience administering statistical programming environments.
  • Hands-on experience with AWS infrastructure including:
    • EC2
    • S3
    • IAM
    • VPC
    • CloudWatch
    • Backup & Recovery
  • Experience building cloud infrastructure from the ground up.
  • Strong Linux or Windows Server administration experience.
  • Experience supporting regulated clinical environments.
  • Excellent scripting skills (PowerShell, Bash, or Python preferred).
  • Strong understanding of infrastructure security, user permissions, and access controls.

Preferred Qualifications

  • SAS Platform Administration experience.
  • Experience migrating statistical computing environments to AWS.
  • CDISC SDTM/ADaM familiarity.
  • Experience supporting Biostatistics or Statistical Programming departments.
  • Knowledge of Git, CI/CD pipelines, Terraform, or Infrastructure as Code.
  • Experience supporting GxP validated systems.
  • Knowledge of Seqera, Nextflow, or scientific computing platforms is a plus.

Desired Skills

  • SAS Programming
  • SAS Macro Development
  • Utility Macros
  • AWS Cloud Infrastructure
  • Infrastructure Administration
  • Linux Administration
  • Windows Server
  • Cloud Architecture
  • Automation
  • Clinical Data
  • Statistical Computing
  • Biotechnology
  • Pharmaceutical Industry
  • GCP
  • FDA Compliance
  • 21 CFR Part 11
  • Infrastructure Design
  • AWS Security
  • Cloud Migration
  • Documentation

Company Description

https://quantive.bio/