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Fda Project Jobs in Reno, NV (NOW HIRING)

... FDA regulatory requirements. Adapts instruction using case studies of medical devices, MATLAB simulation exercises, and design project guidance to support undergraduate biomedical engineering ...

Administrative Specialist

Reno, NV · On-site

$46K - $62K/yr

Maintain a working knowledge of applicable regulatory agencies such as FDA and their related ... special projects as assigned by supervisors or management * Order Office Supplies * Quarterly ...

Director of Quality Assurance

Reno, NV · On-site

$120 - $180/hr

... projects. * Interpret technical product inquiries when requested and provide timely advice as may ... Experience working with and current knowledge of USDA/FDA/ORGANIC Regulations as they pertain to ...

Research Scientist I, Toxicology

Reno, NV · On-site

$85.50 - $104.50/hr

Ability to handle multiple projects, prioritize work and meet deadlines. * Proficiency in the use ... Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits ...

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Showing results 41-53

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:

PROCESS ENGINEER I (SPARKS, NV)

NOW Health Group

Sparks, NV • On-site

Full-time

Re-posted 10 days ago


Job description

Job Summary:
Proactive, analytical, curious and process oriented engineer responsible for providing basic to intermediate process engineering support to achieve safety, quality, and efficiency goals. Uses Electronic Data Gathering Systems and other available means to optimize manufacturing processes, delivering sustainable gains in cost-effectiveness and product performance. Assists with providing plant operations technical process expertise to standardize, develop, and improve existing manufacturing processes. Manages assigned process improvement work of basic to intermediate complexity, ensuring that all agreed-upon timelines and deliverables are met, meeting all expected safety and quality requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
  • Proactively monitors the performance of processes and equipment daily. Troubleshoots, investigates, and finds solutions to manufacturing process issues as they arise. Effectively communicates with Manufacturing, Quality, Maintenance, and Safety to drive proposed solutions.
  • Uses metrics, lean, and other continuous improvement methods to problem-solve and identify inefficiencies and solutions within production and other operational areas.
  • Analyzes issues and data using root cause analysis, identifies opportunities, and assists in designing equipment, processes, and layouts to improve product quality, increase capacity, reduce safety risks, and deliver to best meet customer needs.
  • Provides technical support to operations personnel to troubleshoot and resolve technical problems. Shares knowledge and insights with Manufacturing and Maintenance, including providing formal training as needed.
  • Works with multifunctional teams involving operators, supervisors, management, and additional functional areas to identify and support process improvements and improved efficiencies.
  • Assists with planning, designing, and managing engineering solutions that meet all safety, quality, financial, cGMP, and other regulatory requirements.
  • Standardizes or modifies existing manufacturing processes to increase robustness, reliability, and compliance while reducing non-conforming products, low yields, and product quality issues.
  • Works with other departments to develop and/or update Standard Operating Procedures (SOPs), process documentation, and training materials to support new or modified processes and equipment. Assists with training employees on new and modified processes and equipment.
  • Confers with vendors to assess new technologies that can elevate efficiency. Supports the purchase of recommended equipment, materials, or software and evaluates effectiveness against specifications and goals. Prepares work orders and works closely with Maintenance when installation can be accomplished by internal resources.
  • Ensures that all process improvement projects comply with all safety, GMP, and other relevant regulatory and internal company requirements.
  • Coordinates and manages capital and expense improvement projects of a basic to intermediate level of complexity, developing project objectives/scope; determines project responsibilities; and successfully executes to deliver work on time and within budget

SAFETY RESPONSIBILITY STATEMENT
Supports a culture of safe production and exhibits safe work practices. Actively participates in the safety program by engaging in safety activities. Effectively provides and accepts constructive peer-to-peer feedback on safety performance. Adheres to policies, procedures, SOP's, safe work practices, and safety policies and procedures. Reports ALL workplace incidents to supervisor immediately. Communicates concerns to supervisor, reports hazards, and provides input on prevention. Properly uses, wears, and stores Personal Protective Equipment when required. Participates on safety teams and/or completes safety-related activities as part of regular job responsibilities.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
B.S. degree in Engineering or related discipline and zero to four years related experience and/or training; or equivalent combination of education and experience.
Proficiency in Microsoft Word and Excel. Prior continuous improvement experience, and working experience in a FDA regulated environment using GMP/cGMP processes preferred.
COMPENTENCIES
  • Safety Management - Considers the impact on safety when making decisions.
  • Acts with Integrity - Demonstrates responsible, ethical and honest behavior and models NOW's core values.
  • Attention to Detail - Ability to work accurately with excellent attention to detail skills.
  • Continuous Improvement - High level of adaptability and ability to improve business results through accountability and cost management.
  • Communicates Proactively and Effectively - Ability to clearly convey ideas and concepts verbally and in writing. Keeps others informed and listens to input and feedback. Strong verbal and written communication skills.
  • Customer-Driven - Servant minded leader in which excellent service is provided to all customers and sees business through the eyes of the customer.
  • Decision Making and Planning - Ability to make sound decisions while working under moderate functional supervision and close supervision on new aspects of assignments.
  • Flexibility - Ability to prioritize and to shift directions as business needs require. Maintains a positive attitude and high quality workload. Must be able to work a flexible schedule, including off shifts and weekends.
  • Problem-Solving - Reacts quickly and appropriately to opportunities and problems and makes sound decisions. Follows up in a timely manner to issues not immediately resolved. Excellent problem solving and analytical ability to troubleshoot and resolve issues while driving towards root cause analysis.
  • Project Management (capital or expense) - Ability to develop project objectives and successfully execute project schedule by utilizing good project management methods/tools and resolving problems to deliver projects on time and within budget.
  • Results Driven - Self-driven and motivated to accomplish objectives in a fast-paced environment. Displays a sense of urgency to meet all business objectives.
  • Team Player - Ability to establish and maintain effective working relationships with co-workers, inside and outside the unit and to work effectively both independently and as a team player.
  • Technical - Ability to critically review and interpret technical documentation.
  • Time Management - Ability to establish and maintain effective working relationships with co-workers, inside and outside the unit.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee regularly works at a desk and must use a computer. The employee frequently communicates to employees, vendors and contractors. The employee is required to move from place to place within the facility and to travel to multiple facilities.
The employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms, including overhead reaching and horizontally on a ladder; ascend and/or descend stairs; bend, stoop, kneel, crouch, or crawl.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job while working on the plant floor, the employee regularly works near moving mechanical parts.
When on the plant floor, the employee is frequently exposed to herbal aromas, dust, and/or airborne particles, some classified as allergens or irritants. This position works in all areas of NOW's manufacturing facilities with direct exposure to ingredients (powders and liquids), mixes (powders and liquids), equipment, and packaging. Frequently exposed to all of the FDA designated major food allergens (Milk, Eggs, Fish, Crustacean shellfish (e.g. crab, lobster, shrimp), Tree nuts (e.g., almonds, walnuts, pecans), Wheat and Soybeans, except for peanuts.
The noise level in the work environment is usually moderately loud, and in some areas where louder hearing protection is required.
2025 BENEFITS AT A GLANCE
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Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.