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Live In Fda Scientist Jobs (NOW HIRING)

Mentor Technical Group

Deviations Owner

Juncos, PR · On-site

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical ...

Jobot

Senior FDA Attorney

Pine Brook, NJ · On-site +1

$250K - $400K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

The role may be based in the firm's Pine Brook, New Jersey or New York City office. A fully remote ... The firm is focused exclusively on healthcare and life sciences and represents clients across the ...

Mentor Technical Group

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical ...

Tempus AI

Senior Quality Engineer

Redwood City, CA · On-site

$108K - $146K/yr

S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines. • 5+ years experience in FDA regulated domain (e.g. medical device ...

Mentor Technical Group

Network Engineer

Salinas, PR · On-site

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical ...

Pacelabs

PLS Associate Scientist I

Lebanon, NJ · On-site

$25/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Join our mission to continuously move science forward; to innovate and advance all aspects of our ... Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus PHYSICAL/MENTAL ...

Pace

PLS Associate Scientist I

Lebanon, NJ · On-site

$25/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Join our mission to continuously move science forward; to innovate and advance all aspects of our ... Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus PHYSICAL/MENTAL ...

Pacelabs

PLS Associate Scientist I

Lebanon, NJ

$25/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Join our mission to continuously move science forward; to innovate and advance all aspects of our ... Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus PHYSICAL/MENTAL ...

Pace

PLS Associate Scientist I

Lebanon, NJ · On-site

$25/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Join our mission to continuously move science forward; to innovate and advance all aspects of our ... Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus PHYSICAL/MENTAL ...

Pace Analytical Services

PLS Associate Scientist I

Lebanon, NJ

$25/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Join our mission to continuously move science forward; to innovate and advance all aspects of our ... Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus PHYSICAL/MENTAL ...

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All JobsLive In Fda Scientist Jobs

Live In Fda Scientist information

What is a live in FDA scientist?

A Live In FDA Scientist typically refers to a regulatory scientist who works for the U.S. Food and Drug Administration (FDA) and may be involved in on-site or continuous monitoring of studies, often in clinical or laboratory settings. Their role includes evaluating scientific data, ensuring compliance with federal regulations, and overseeing the safety and efficacy of products such as drugs, biologics, or medical devices. Live-in positions might be required for research facilities needing 24/7 oversight, although such roles are rare and specialized. These scientists play a crucial role in public health by supporting the FDA’s mission to protect consumers.

What are some unique challenges faced by a live in FDA scientist, and how can they be managed?

A Live-In FDA Scientist often works in environments such as research facilities or clinical trial sites where on-site presence is essential. This setup can present challenges like maintaining work-life balance, adapting to extended hours, and managing confidentiality due to the sensitive nature of ongoing research. Successful candidates typically develop strong time management skills, set clear personal boundaries, and foster open communication with team members to ensure both professional responsibilities and personal well-being are balanced. Collaboration with multidisciplinary teams is frequent, and adaptability is key to thriving in this dynamic role.

What are the key skills and qualifications needed to thrive as a live in FDA scientist, and why are they important?

To thrive as an FDA Scientist, you need a strong background in life sciences or chemistry, typically with an advanced degree (MS or PhD) and experience in research or regulatory affairs. Familiarity with laboratory instrumentation, data analysis software, and FDA regulatory systems is essential, and certifications like RAC (Regulatory Affairs Certification) can be advantageous. Attention to detail, critical thinking, and excellent communication skills help you interpret data accurately and collaborate effectively with multidisciplinary teams. These skills ensure scientific integrity, regulatory compliance, and the advancement of public health through safe and effective products.

What is the difference between Live In Fda Scientist vs Fda Reviewer?

AspectLive In Fda ScientistFda Reviewer
Required credentialsBachelor's or Master's in Life Sciences, relevant experienceSimilar credentials, often with advanced degrees
Work environmentOn-site, often in government or research facilitiesOffice-based, reviewing submissions at FDA headquarters or regional offices
Employer and industry usageFederal government, regulatory scienceFederal government, regulatory review
Common search intentJob duties, qualifications, work conditionsComparison of roles, responsibilities, career path

The Live In Fda Scientist and Fda Reviewer roles both require scientific expertise and federal employment credentials. While the Live In Fda Scientist often involves conducting research and scientific analysis on-site, the Fda Reviewer primarily focuses on evaluating regulatory submissions and documentation. Both roles are integral to FDA operations, but they differ in daily tasks and work environment, with the scientist more research-oriented and the reviewer more review-focused.

How much do live in FDA scientists make?

Live-in FDA scientists typically earn a salary comparable to federal scientific positions, which can range from approximately $70,000 to over $130,000 annually depending on experience, education, and location. They often receive benefits such as health insurance and retirement plans, and may work in regulated environments requiring specialized certifications.

What cities are hiring for Live In Fda Scientist jobs?

Cities with the most Live In Fda Scientist job openings:

What are the most commonly searched types of Fda Scientist jobs?

The most popular types of Fda Scientist jobs are:

What states have the most Live In Fda Scientist jobs?

States with the most job openings for Live In Fda Scientist jobs include:

Live In Fda Scientist jobs near you

Remote Regulatory Affairs contractor

Globalchannelmanagement

Atlanta, GA • Remote

$99 - $100/hr

Full-time

Re-posted 22 days ago

Job description

Remote Regulatory Affairs contractor requires:

  • Bachelor's degree in engineering, life sciences, regulatory affairs, legal or a related field
  • 5-10 years+ of global medical device regulatory experience
  • Proven experience preparing, writing and submitting FDA 510k submissions (end to end)
  • Experience with ophthalmic devices, capital equipment, diagnostic devices, software in medical devices, cybersecurity
  • Strong working knowledge of:
    • FDA regulations (21 Parts 807, 820)
    • FDA guidance documents and eStar requirements
    • Experience with Canadian regulations, EU MDR (2017/745) including Class lla, Tech docs Annex ll/lll
  • Demonstrated ability to work independently as a contractor in a fast-paced environment
  • Experience filing medical device submissions in China and other countries
  • Experience with audiology devices
  • Experience with artificial-intelligence enabled devices
  • Strong technical writing and documentation skills
  • Ability to translate complex technical information into regulatory submissions
  • Detail-oriented with strong organization skills
  • Effective communicator across technical and non-technical stakeholders
  • Ability to manage multiple deliverables and timelines

DUTIES:

  • FDA 510(k) submission
  • Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance
  • Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents)
  • Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format,
  • Lead submission lifecycle activities, including:
    • Acceptance Review support (RTA readiness)
    • Substantive Review coordination
    • Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications
    • Updating submission content and modules as required
  • Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process.
  • Provide regulatory leadership through FDA clearance.
  • EU MDR Technical Documentation Support
  • Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements.
  • Perform critical review and gap analysis of EU MDR technical file
  • Provide targeted recommendations to ensure audit-readiness and Notified Body acceptance
  • Lead or support submission to obtain CE Mark
  • Health Canada submission
  • Global Regulatory Strategy and Advisory