Location Hybrid (minimum 3 days onsite) - Andover, MA OR Remote About the job you're considering ... Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory ...
Location Hybrid (minimum 3 days onsite) - Andover, MA OR Remote About the job you're considering ... Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory ...
Regulatory Coordinator - Sarcoma Clinical Trials
Brookline, MA · On-site +1
$55K - $61K/yr
This position's work location is fully remote, never on campus. The selected candidate may only ... Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual ...
Regulatory Coordinator - Sarcoma Clinical Trials
Brookline, MA · On-site +1
$55K - $61K/yr
This position's work location is fully remote, never on campus. The selected candidate may only ... Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual ...
We developed and are commercializing the first and only FDA and EC approved medicine for adults ... Market Access. This role is open for remote consideration #LI-Remote This role is preferred ...
Quick apply
We developed and are commercializing the first and only FDA and EC approved medicine for adults ... Market Access. This role is open for remote consideration #LI-Remote This role is preferred ...
37599353 Remote Senior Manager, Clinical Supply Chain 12 Months Contract Sigma Systems is currently ... Significant experience in supply chain and distribution management in pharmaceutical or other FDA ...
Quick apply
37599353 Remote Senior Manager, Clinical Supply Chain 12 Months Contract Sigma Systems is currently ... Significant experience in supply chain and distribution management in pharmaceutical or other FDA ...
Sr. Director, RA/QA Strategy & Business Integration
Boston, MA · Remote
$230K - $288K/yr
Strong understanding of global regulatory environments (e.g., FDA, IVDR) and risk-based decision ... This position also qualifies for Foundation Medicine's benefits. #LI-Remote Foundation Medicine ...
Sr. Director, RA/QA Strategy & Business Integration
Boston, MA · Remote
$230K - $288K/yr
Strong understanding of global regulatory environments (e.g., FDA, IVDR) and risk-based decision ... This position also qualifies for Foundation Medicine's benefits. #LI-Remote Foundation Medicine ...
Instructional Designer
Boston, MA · Remote
$45 - $55/hr
Remote Start Date Is: Flexible Duration: 2 Month Contract (ad hoc) Compensation Range: $45-$55/hour ... Knowledge of FDA-regulated products, IEC 62366, Human Factors Engineering, or Software as a Medical ...
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Instructional Designer
Boston, MA · Remote
$45 - $55/hr
Remote Start Date Is: Flexible Duration: 2 Month Contract (ad hoc) Compensation Range: $45-$55/hour ... Knowledge of FDA-regulated products, IEC 62366, Human Factors Engineering, or Software as a Medical ...
... 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.
Quick apply
... 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.
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 ...
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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 ...
Automation Validation Lead
Andover, MA · On-site +1
Follow FDA Title 21 CFR Part 11 for Data Integrity Compliance Draft, review or approve automation ... Windows operating systems Windows Terminal Services/Remote Desktop VMWare Dell VRTX familiarity is ...
Automation Validation Lead
Andover, MA · On-site +1
Follow FDA Title 21 CFR Part 11 for Data Integrity Compliance Draft, review or approve automation ... Windows operating systems Windows Terminal Services/Remote Desktop VMWare Dell VRTX familiarity is ...
... remote based (can also be onsite in Chaska MN). At Danaher Diagnostics, our vision is to be the ... Design clinical studies and evidence strategies supporting global regulatory submissions (e.g., FDA ...
... remote based (can also be onsite in Chaska MN). At Danaher Diagnostics, our vision is to be the ... Design clinical studies and evidence strategies supporting global regulatory submissions (e.g., FDA ...
Principal Clinical Scientist
Boston, MA · On-site +1
... remote based (can also be onsite in Chaska, MN). At Danaher Diagnostics, our vision is to be the ... Design clinical studies and evidence strategies supporting global regulatory submissions (e.g., FDA ...
Principal Clinical Scientist
Boston, MA · On-site +1
... remote based (can also be onsite in Chaska, MN). At Danaher Diagnostics, our vision is to be the ... Design clinical studies and evidence strategies supporting global regulatory submissions (e.g., FDA ...
Principal Statistical Programmer
Boston, MA · Remote
$149K - $223K/yr
Provides leadership to ensure compliance with Vertex SOP'S and FDA/ICH/GCP regulations * Provides ... Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be ...
Principal Statistical Programmer
Boston, MA · Remote
$149K - $223K/yr
Provides leadership to ensure compliance with Vertex SOP'S and FDA/ICH/GCP regulations * Provides ... Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be ...
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 ...
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 ...
Associate Director, Clinical Operations
Waltham, MA · On-site +1
$185K - $215K/yr
Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring ... Excellent knowledge of GCP, ICH, and FDA regulations * Experience with SOP review and development ...
Associate Director, Clinical Operations
Waltham, MA · On-site +1
$185K - $215K/yr
Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring ... Excellent knowledge of GCP, ICH, and FDA regulations * Experience with SOP review and development ...
Senior Commercial Contracts Manager
Boston, MA · On-site +1
Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we ... Support commercialization of Beacon's FDA-cleared devices (Waveband, SleepView) by ensuring supply ...
Senior Commercial Contracts Manager
Boston, MA · On-site +1
Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we ... Support commercialization of Beacon's FDA-cleared devices (Waveband, SleepView) by ensuring supply ...
Senior Commercial Contracts Manager
Boston, MA · On-site +1
Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we ... Support commercialization of Beacon's FDA-cleared devices (Waveband, SleepView) by ensuring supply ...
Senior Commercial Contracts Manager
Boston, MA · On-site +1
Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we ... Support commercialization of Beacon's FDA-cleared devices (Waveband, SleepView) by ensuring supply ...
Senior Clinical Trial Manager
Cambridge, MA · On-site +1
Perform clinical research site activities, which can include onsite or remote monitoring, co ... Strong working knowledge of GCP, ICH, and FDA regulations. About Us Channeling Energy. Changing ...
Senior Clinical Trial Manager
Cambridge, MA · On-site +1
Perform clinical research site activities, which can include onsite or remote monitoring, co ... Strong working knowledge of GCP, ICH, and FDA regulations. About Us Channeling Energy. Changing ...
Project Manager
Cambridge, MA · On-site +1
Location: Boston, or Remote USA, Full-time Company Description Cognito Therapeutics, Inc. is a ... We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility ...
Project Manager
Cambridge, MA · On-site +1
Location: Boston, or Remote USA, Full-time Company Description Cognito Therapeutics, Inc. is a ... We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility ...
Senior Engineer, Process Validation
Boston, MA · On-site +1
$100K - $130K/yr
... FDA guidance, EU GMP Annex 15, and lifecycle approach. * Lead the planning, execution, and ... We recognize the benefits of flexible, remote working arrangements for eligible roles and are ...
Senior Engineer, Process Validation
Boston, MA · On-site +1
$100K - $130K/yr
... FDA guidance, EU GMP Annex 15, and lifecycle approach. * Lead the planning, execution, and ... We recognize the benefits of flexible, remote working arrangements for eligible roles and are ...
Senior Engineer, Process Validation
Boston, MA · On-site +1
$100K - $130K/yr
... FDA guidance, EU GMP Annex 15, and lifecycle approach. * Lead the planning, execution, and ... We recognize the benefits of flexible, remote working arrangements for eligible roles and are ...
Senior Engineer, Process Validation
Boston, MA · On-site +1
$100K - $130K/yr
... FDA guidance, EU GMP Annex 15, and lifecycle approach. * Lead the planning, execution, and ... We recognize the benefits of flexible, remote working arrangements for eligible roles and are ...
Remote Fda information
See Boston, MA salary details
$27.8K - $42.3K
12% of jobs
$53.8K is the 25th percentile. Wages below this are outliers.
$42.3K - $56.7K
17% of jobs
$56.7K - $71.2K
14% of jobs
The median wage is $81K / yr.
$71.2K - $85.6K
12% of jobs
$85.6K - $100.1K
12% of jobs
$113.5K is the 75th percentile. Wages above this are outliers.
$100.1K - $114.5K
11% of jobs
$114.5K - $129K
7% of jobs
$129K - $143.4K
6% of jobs
$143.4K - $157.9K
4% of jobs
$157.9K - $172.4K
4% of jobs
$172.4K - $186.8K
2% of jobs
$27.8K
$94.9K
$186.8K
How much do remote fda jobs pay per year?
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?
What are the most commonly searched types of Fda jobs in Boston, MA?
The most popular types of Fda jobs in Boston, MA are:
What are popular job titles related to Remote Fda jobs in Boston, MA?
For Remote Fda jobs in Boston, MA, the most frequently searched job titles are:
What job categories do people searching Remote Fda jobs in Boston, MA look for?
The top searched job categories for Remote Fda jobs in Boston, MA are:
What cities near Boston, MA are hiring for Remote Fda jobs?
Cities near Boston, MA with the most Remote Fda job openings:

Sr. Software Developer Quality Engineer- Medical Devices
Burlington, MA • On-site, Remote
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 21 days ago
United Airlines rating
7.9
Based on 343 frontline employees who took The Breakroom Quiz
8th of 26 rated airlines
Job description
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days arethe same.
Location
Hybrid (minimum 3 days onsite) - Andover, MA OR Remote
About the job you're considering
Capgemini Engineering is seeking a Senior Design Quality Engineer- Medical Devices. You will be responsible for ensuring endtoend design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and postmarket activities.
Your role
- Serving as the Senior Design Quality Engineer on product development teams, ensuring compliance with design controls(specifically software) across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
- Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
- Responsible for leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
- Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
- Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
- Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
- Responsible for leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
- Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)
Your skills and experience
- Bachelor's degree in business, Engineering, Project Management, Computer Science, or a related discipline.
- 10+ years of experience in software quality assurance within regulated environments (medical device preferred)
- Should have embedded development/ Digital Platform background Or exposure to embedded development / Digital Platform within Medical Devices domain (preference class II OR III)
- Experience supporting IDE, PMA, or similar regulatory pathways with understanding of clinical evidence requirements
- Strong understanding of SDLC and design controls in regulated environments (e.g., traceability, DHF)
- Proven experience reviewing and improving SOPs or quality processes for regulatory compliance
- Hands-on experience with software verification and validation using risk-based approaches aligned with FDA expectations
- Familiarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814).
- Experience with test management, defect tracking, and quality documentation tools
- Strong analytical, documentation, and stakeholder communication skills with ability to influence quality decisions
The base compensation range for this role in the posted location is: 68,911 - 150,350
Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.
The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.
These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.
It is not typical for candidates to be hired at or near the top of the posted compensation range.
In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.
Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:
- Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
- Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
- Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
- Life and disability insurance
- Employee assistance programs
- Other benefits as provided by local policy and eligibility
Important Notice: Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini's discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.
Disclaimers
Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect. We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.
This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.
Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.
Click the following link for more information on your rights as an Applicant in the United States. http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.
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About United Airlines
Sourced by ZipRecruiter
United Airlines is embarking on an exciting journey to become the best airline in aviation history. Our purpose, "Connecting People, Uniting the World," extends beyond transportation, emphasizing our commitment to uplift and create opportunities in the places we serve. With a global presence and diverse workforce, we value inclusivity and are dedicated to hiring tens of thousands of individuals across various roles. Our comprehensive benefits package, including perks like space available travel, parental leave, and 401k, aims to support your well-being and growth.
Industry
Aviation
Company size
10,000+ Employees
Headquarters location
Chicago, IL, US
Year founded
1926