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Remote Fda Jobs in Edison, NJ (NOW HIRING)

micro1 AI

Regulatory Affairs Specialist

Paterson, NJ · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

New

micro1 AI

Compliance Officers

Elizabeth, NJ · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

New

micro1 AI

Compliance Officers

Paterson, NJ · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

New

System One

Biostatistician

Jersey City, NJ · Remote

$60 - $65/hr

Jersey City, NJ 07302 (Remote) Schedule: 24 hours/week (Choose: 9:00AM - 5:00PM) Compensation: $60 ... FDA regulations and industry standards. This is a part-time consulting position ideal for a ...

System One

Biostatistician

Jersey City, NJ · Remote

$60 - $65/hr

Jersey City, NJ 07302 (Remote) Schedule: 24 hours/week (Choose: 9:00AM - 5:00PM) Compensation: $60 ... FDA regulations and industry standards. This is a part-time consulting position ideal for a ...

System One

Biostatistician

Jersey City, NJ · Remote

$60 - $65/hr

Jersey City, NJ 07302 (Remote) Schedule: 24 hours/week (Choose: 9:00AM - 5:00PM) Compensation: $60 ... FDA regulations and industry standards. This is a part-time consulting position ideal for a ...

micro1 AI

Regulatory Affairs Specialist

New York, NY · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

New

micro1 AI

Compliance Officers

Newark, NJ · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

New

micro1 AI

Compliance Officers

Jersey City, NJ · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

New

micro1 AI

Compliance Officers

New York, NY · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

New

micro1 AI

Regulatory Affairs Specialist

Jersey City, NJ · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...

New

Vitalief

Senior Vice President, Research

New Brunswick, NJ · On-site +1

$300K - $400K/yr

Primarily remote position with up to 25% travel to the health system's New Jersey locations ... Comprehensive knowledge of clinical research regulations, FDA requirements, GCP, IRB processes ...

FastTek

Compliance Analyst

Newark, NJ · Remote

Rename and file FDA letters. * Rename and file other OGA/PGA declarations. Ancillary Duties * Help ... Remote; standard hours. Additional Information: At FastTek Global, Our Purpose is Our People and ...

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All JobsFda JobsRemote Fda JobsRemote Fda Jobs in Edison, NJ

Remote Fda information

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 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 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 are popular job titles related to Remote Fda jobs in Edison, NJ? For Remote Fda jobs in Edison, NJ, the most frequently searched job titles are:
What job categories do people searching Remote Fda jobs in Edison, NJ look for? The top searched job categories for Remote Fda jobs in Edison, NJ are:
What cities near Edison, NJ are hiring for Remote Fda jobs? Cities near Edison, NJ with the most Remote Fda job openings:
Remote Fda jobs near you
Infographic showing various Remote Fda job openings in Edison, NJ as of August 2026, with employment types broken down into 79% Full Time, 15% Part Time, 5% Contract, and 1% Nights. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution.

Regulatory Affairs Specialist

micro1 AI

Paterson, NJ • Remote

$50 - $70/hr

Part-time

Posted 3 days ago

New

Job description

Role Title: Regulatory Affairs Specialist


Role Type: Contractor


Location: Remote


micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project focused on AI innovation in regulatory documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.


Scope of Work

  1. Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads, determining if drafted responses meet regulatory expectations.
  2. Apply expert judgment to review clinical documentation, assessing whether conclusions are substantiated, commitments are properly scoped, and records can withstand regulatory scrutiny.
  3. Distinguish between substantively adequate and superficially polished responses, articulating clear rationales for any deficiencies.
  4. Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims within or between documents.
  5. Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines rather than subjective impressions.
  6. Collaborate asynchronously and communicate complex regulatory concepts clearly in both written and verbal form.


Preferred Qualifications

  1. 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.
  2. Documented experience drafting or leading responses to health authority information requests, particularly for ongoing regulatory filings.
  3. Demonstrated working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of at least one major regulatory body (FDA, EMA, MHRA, PMDA, or Health Canada).
  4. Proven ability to critically read clinical or safety documents to identify regulatory risks, unsupported statements, and potential reviewer concerns.
  5. Exceptional written communication skills, with the capability to convey regulatory reasoning clearly, concisely, and defensibly.
  6. Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.
  7. Experience engaging with multiple regions or agencies, prior health authority reviewer/assessor background, or familiarity with AI-assisted regulatory tools (all considered valuable).

Apply