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Fda Project Jobs in Reno, NV (NOW HIRING)

micro1 AI

Regulatory Affairs Specialist

Sparks, NV · 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 ...

micro1 AI

Compliance Officers

Reno, NV · 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 ...

micro1 AI

Regulatory Affairs Specialist

Reno, NV · 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 ...

Hamilton Medical, Inc.

Quality Engineer

Reno, NV

$75K - $85K/yr

Effectively engage in project as the Quality Engineering resource. * Formulates or assists in ... FDA 21 CFR 820. * Auditing education and experience. * Ability to work effectively with various ...

Hamilton Company

Senior Manufacturing Engineer

Reno, NV · On-site

$90 - $140/hr

Support company policies, procedures, FDA regulations and good manufacturing practices. * Handle customer complaints and failure reports. * Plan and execute production improvement projects from ...

Hamilton Medical, Inc.

Quality Engineer

Reno, NV · On-site

$75K - $85K/yr

Effectively engage in project as the Quality Engineering resource. * Formulates or assists in ... FDA 21 CFR 820. * Auditing education and experience. * Ability to work effectively with various ...

BHI Energy

Assembler

Reno, NV · On-site

$16 - $19.75/hr

... projects * Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA Regulations. * Identify and report any product quality problems * Facilitate ...

Hamilton Medical, Inc.

Quality Engineer

Reno, NV · On-site

$71K - $92K/yr

Effectively engage in project as the Quality Engineering resource. * Formulates or assists in ... FDA 21 CFR 820. * Auditing education and experience. * Ability to work effectively with various ...

Hamilton Company

Senior Manufacturing Engineer

Reno, NV · On-site

$110K - $150K/yr

... FDA regulations, and good manufacturing practices. * Handle customer complaints and failure reports. * Responsible for planning and executing production improvement projects from concept to ...

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Showing results 21-40

All JobsFda Project JobsFda Project Jobs in Reno, NV

Fda Project information

What is an FDA project?

An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.

What are the key skills and qualifications needed to thrive as an FDA project manager?

To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.

What are some common challenges faced by professionals working on FDA project teams?

Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.

What is the difference between Fda Project vs Fda Reviewer?

AspectFda ProjectFda Reviewer
Required CredentialsTypically requires a background in life sciences, engineering, or related fields; often includes project management certificationsRequires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience
Work EnvironmentProject teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firmsRegulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions
Employer & Industry UsageUsed in project management contexts to oversee regulatory submissions and complianceUsed in regulatory review processes to evaluate drug, device, or food applications

In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.

What qualifications do you need to work for the FDA?

To work as an FDA project professional, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or health sciences. Advanced positions may require a master's degree or higher, along with relevant experience, knowledge of regulatory guidelines, and strong analytical skills. Certifications like Regulatory Affairs Certification (RAC) can also enhance qualifications.

What cities near Reno, NV are hiring for Fda Project jobs?

Cities near Reno, NV with the most Fda Project job openings:

Fda Project jobs near you

Regulatory Affairs Specialist

micro1 AI

Sparks, NV • Remote

$50 - $70/hr

Part-time

Posted 16 days ago

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).

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