Preparing international regulatory submissions and FDA submissions which may include device 510(k ... Scientific or engineering field preferred. 5+ years of medical device regulatory affairs experience.
Preparing international regulatory submissions and FDA submissions which may include device 510(k ... Scientific or engineering field preferred. 5+ years of medical device regulatory affairs experience.
Familiarity with regulatory expectations (FDA/ICH) for nonclinical development. Preferred ... We are a remote-first company, with occasional travel for in-person team meetings or scientific ...
Familiarity with regulatory expectations (FDA/ICH) for nonclinical development. Preferred ... We are a remote-first company, with occasional travel for in-person team meetings or scientific ...
FDA submission experience is highly desirable. * Strong SAS programming and Statistical background ... or Scientific Discipline. Remote Principal Statistical Programmer duties: * Lead on clinical ...
FDA submission experience is highly desirable. * Strong SAS programming and Statistical background ... or Scientific Discipline. Remote Principal Statistical Programmer duties: * Lead on clinical ...
Senior Scientist, Analytical Development & Quality Control (ADQC)
Carlsbad, CA ยท On-site +1
$113K - $150K/yr
We continue to invest time, money and energy into making our onsite, hybrid and remote work ... Familiarity with ICH and FDA method validation guidelines, including phase-appropriate strategies
Senior Scientist, Analytical Development & Quality Control (ADQC)
Carlsbad, CA ยท On-site +1
$113K - $150K/yr
We continue to invest time, money and energy into making our onsite, hybrid and remote work ... Familiarity with ICH and FDA method validation guidelines, including phase-appropriate strategies
Senior Scientist, Analytical Development & Quality Control (ADQC)
Carlsbad, CA ยท On-site +1
$113K - $150K/yr
We continue to invest time, money and energy into making our onsite, hybrid and remote work ... Familiarity with ICH and FDA method validation guidelines, including phase-appropriate strategies
Senior Scientist, Analytical Development & Quality Control (ADQC)
Carlsbad, CA ยท On-site +1
$113K - $150K/yr
We continue to invest time, money and energy into making our onsite, hybrid and remote work ... Familiarity with ICH and FDA method validation guidelines, including phase-appropriate strategies
Data Scientist II, Outcomes Research
Redwood City, CA ยท On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Redwood City, CA ยท On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the ... Strong understanding of global pharmacovigilance regulations including FDA, EMA, ICH, MHRA, and ...
San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the ... Strong understanding of global pharmacovigilance regulations including FDA, EMA, ICH, MHRA, and ...
Data Scientist II, Outcomes Research
Boston, MA ยท On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Boston, MA ยท On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Chicago, IL ยท On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Chicago, IL ยท On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
... FDA Our team is comprised of Industry Leaders in Technology, Regulations and Life Sciences ... This Position is Work form Home - Remote Position for All USA location only. Compliance Group ...
... FDA Our team is comprised of Industry Leaders in Technology, Regulations and Life Sciences ... This Position is Work form Home - Remote Position for All USA location only. Compliance Group ...
Data Scientist II, Outcomes Research
Boston, MA ยท On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Data Scientist II, Outcomes Research
Boston, MA ยท On-site +1
$100K - $150K/yr
Hands-on experience contributing to regulatory submissions to the FDA or other health authorities ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...
Director, Clinical Science
Boston, MA ยท On-site +1
$86K - $118K/yr
Lead clinical strategy and evidence development for FDA, CE Mark, and other regulatory pathways ... or remote patient monitoring. * Familiarity with machine learning-enabled medical devices ...
Quick apply
Director, Clinical Science
Boston, MA ยท On-site +1
$86K - $118K/yr
Lead clinical strategy and evidence development for FDA, CE Mark, and other regulatory pathways ... or remote patient monitoring. * Familiarity with machine learning-enabled medical devices ...
Director, Clinical Science
Boston, MA ยท On-site +1
$86K - $118K/yr
Lead clinical strategy and evidence development for FDA, CE Mark, and other regulatory pathways ... or remote patient monitoring. * Familiarity with machine learning-enabled medical devices ...
Director, Clinical Science
Boston, MA ยท On-site +1
$86K - $118K/yr
Lead clinical strategy and evidence development for FDA, CE Mark, and other regulatory pathways ... or remote patient monitoring. * Familiarity with machine learning-enabled medical devices ...
Remote (EST time) Duration: Long term Position Summary We are seeking an experienced QA Lead / Test ... Ensure systems comply with FDA regulations, 21 CFR Part 11, and data integrity standards (ALCOA+
Remote (EST time) Duration: Long term Position Summary We are seeking an experienced QA Lead / Test ... Ensure systems comply with FDA regulations, 21 CFR Part 11, and data integrity standards (ALCOA+
Director-Clinical development, Ophthalmology ( Remote)
Ambler, PA ยท Remote
$81K - $111K/yr
Clinical Science Job Summary: Responsible for driving the US or global clinical development ... Has working knowledge of GCP, ICH, US FDA and EMEA regulations, knowledge of relevant FDA ...
Quick apply
Director-Clinical development, Ophthalmology ( Remote)
Ambler, PA ยท Remote
$81K - $111K/yr
Clinical Science Job Summary: Responsible for driving the US or global clinical development ... Has working knowledge of GCP, ICH, US FDA and EMEA regulations, knowledge of relevant FDA ...
LIMS SME/Business Analyst
Atlanta, GA ยท Remote
This is a remote position so the candidate can live anywhere in the USA. The position will require ... Provide strategic direction to the IT, Scientific, and Management teams. Define data migration ...
LIMS SME/Business Analyst
Atlanta, GA ยท Remote
This is a remote position so the candidate can live anywhere in the USA. The position will require ... Provide strategic direction to the IT, Scientific, and Management teams. Define data migration ...
Director-Clinical development, Ophthalmology ( Remote)
Ambler, PA ยท Remote
$81K - $111K/yr
Clinical Science Job Summary: Responsible for driving the US or global clinical development ... Has working knowledge of GCP, ICH, US FDA and EMEA regulations, knowledge of relevant FDA ...
Quick apply
Director-Clinical development, Ophthalmology ( Remote)
Ambler, PA ยท Remote
$81K - $111K/yr
Clinical Science Job Summary: Responsible for driving the US or global clinical development ... Has working knowledge of GCP, ICH, US FDA and EMEA regulations, knowledge of relevant FDA ...
Remote Reporting to : Executive Director, Regulatory Science Orchard Therapeutics, a Kyowa Kirin ... Prepare FDA meeting requests, briefing documents, coordinate and prepare cross-functional teams for ...
Remote Reporting to : Executive Director, Regulatory Science Orchard Therapeutics, a Kyowa Kirin ... Prepare FDA meeting requests, briefing documents, coordinate and prepare cross-functional teams for ...
Senior Specialist, Medical Writing, Remote US
Denver, CO ยท Remote
$106K - $149K/yr
This position is US Remote based. Posting locations are listed for job board tags only. How you ... Familiarity with FDA PMA applications. * Good knowledge of scientific research methodology, device ...
Senior Specialist, Medical Writing, Remote US
Denver, CO ยท Remote
$106K - $149K/yr
This position is US Remote based. Posting locations are listed for job board tags only. How you ... Familiarity with FDA PMA applications. * Good knowledge of scientific research methodology, device ...
Senior Specialist, Medical Writing, Remote US
Phoenix, AZ ยท Remote
$106K - $149K/yr
This position is US Remote based. Posting locations are listed for job board tags only. How you ... Familiarity with FDA PMA applications. * Good knowledge of scientific research methodology, device ...
Senior Specialist, Medical Writing, Remote US
Phoenix, AZ ยท Remote
$106K - $149K/yr
This position is US Remote based. Posting locations are listed for job board tags only. How you ... Familiarity with FDA PMA applications. * Good knowledge of scientific research methodology, device ...
Remote Fda Scientist information
See salary details
$83.5K - $91.5K
5% of jobs
$91.5K - $99.4K
6% of jobs
$99.4K - $107.4K
12% of jobs
$108.6K is the 25th percentile. Wages below this are outliers.
$107.4K - $115.3K
12% of jobs
$115.3K - $123.3K
14% of jobs
The median wage is $124.1K / yr.
$123.3K - $131.2K
15% of jobs
$131.2K - $139.2K
11% of jobs
$140.2K is the 75th percentile. Wages above this are outliers.
$139.2K - $147.1K
11% of jobs
$147.1K - $155.1K
7% of jobs
$155.1K - $163K
4% of jobs
$163K - $171K
4% of jobs
$83.5K
$127K
$171K
How much do remote fda scientist jobs pay per year?
What is a Remote FDA Scientist?
What is the difference between Remote Fda Scientist vs Remote Fda Reviewer?
| Aspect | Remote Fda Scientist | Remote Fda Reviewer |
|---|---|---|
| Required Credentials | Advanced degree in life sciences, relevant certifications | Similar credentials, often with additional regulatory training |
| Work Environment | Research labs, regulatory agencies, or remote settings | Primarily review submissions remotely, office or home-based |
| Industry Usage | Research, development, and regulatory compliance | Reviewing and approving drug, device, or food applications |
| Common Search Intent | Understanding roles, qualifications, and remote opportunities | Differences in responsibilities, qualifications, and remote work |
Remote Fda Scientists focus on research and development activities, while Remote Fda Reviewers primarily evaluate submissions for approval. Both roles require similar scientific credentials and often operate remotely within the regulatory industry. The main difference lies in their core responsibilities: scientists conduct research, whereas reviewers assess regulatory submissions.
What are the key skills and qualifications needed to thrive as a Remote FDA Scientist, and why are they important?
What are some common challenges faced by Remote FDA Scientists in maintaining effective communication with regulatory teams?
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Posted 27 days ago
Job description
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.ย
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.
Required: (Remote Opportunity - Temp to Perm)
The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.
In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth.
The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.
Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.
Key responsibilities:
Lead Regulatory Associates or Specialists in addition to work as an individual contributor
Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions)
Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release.ย
Develop Regulatory Strategies for new or modified products and prepare project plans & budgets.
Monitor and provide management with impact of changes in the Regulatory environment.
Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.
Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators.
Support Design Control process.
Prepare Rational to file documentation for modifications to devices when appropriate.
Participate in FDA & other notified body Inspections.
Author and/or review regulatory procedures and update as necessary.
Review change control documents and ascertain Regulatory impact for external and internal documents.
Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information.
Review promotional material and labeling for regulatory compliance.
Required qualifications:(Remote Opportunity)
Bachelor's degree required. Scientific or engineering field preferred.
5+ years of medical device regulatory affairs experience.
Must have authored 510(k) submissions
Must have knowledge of U.S. FDA regulations and standards
3+ years of experience interacting with FDA and/or other regulatory agencies
Experience with devices containing software is strongly preferred.
Must work well in team environments
Must demonstrate leadership skills in team setting.
Proven analytical abilities
Solid understanding of manufacturing and change control, and an awareness of regulatory trends
To know more on this position or to schedule an interview, please contact;
Ujjwal Mane
973-805-7557
ujjwal.mane[@]collabera.com