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Fda Project Jobs in Hampton, VA (NOW HIRING)

Instant Systems Inc

Project Manager

Norfolk, VA · On-site

Ensure compliance with medical device regulations (e.g., FDA, ISO 13485, ISO 9001) throughout the project lifecycle. * Monitor and track project performance, proactively identifying risks and ...

Instant Systems Inc

Project Manager

Norfolk, VA

Ensure compliance with medical device regulations (e.g., FDA, ISO 13485, ISO 9001) throughout the project lifecycle Monitor and track project performance, proactively identifying risks and ...

Instant Systems Inc

Project Manager

Norfolk, VA · On-site

Ensure compliance with medical device regulations (e.g., FDA, ISO 13485, ISO 9001) throughout the project lifecycle. * Monitor and track project performance, proactively identifying risks and ...

Omnicom

Project Coordinator

Williamsburg, VA · On-site

... FDA and FTC and other applicable federal or state regulations ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES: The Project Coordinator must be able to perform the following duties and functions:

Omnicom

Project Coordinator

Williamsburg, VA · On-site

... FDA and FTC and other applicable federal or state regulations ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES: The Project Coordinator must be able to perform the following duties and functions:

Aerotek

Multi Craft Maintenance Technician

Chesapeake, VA · On-site

$39 - $42/hr

... projects and equipment upgrades to enhance performance, safety, and efficiency on the production ... Follow and uphold GMP, HACCP, FDA, and site safety standards in all maintenance activities to ...

PrideStaff

Assistant Warehouse Manager

Suffolk, VA · On-site

$75K - $80K/yr

Demonstrated ability to lead through influence, manage projects, and build credibility with frontline teams. * Preferred knowledge of Lean, 5S, Kaizen, BRCGS, and FDA compliance regulations.

New

Omnicom

Senior Ambassador Manager

Williamsburg, VA · On-site

... projects from start to finish, including contracting, needs assessment, project management ... Food and Drug Administration (FDA) as they apply to the Ambassador Program Understand ...

Omnicom

Ambassador Manager

Williamsburg, VA · On-site

... projects from start to finish, including contracting, needs assessment, project management ... Food and Drug Administration (FDA) as they apply to the Ambassador Program * Understand ...

Omnicom

Senior Ambassador Manager

Williamsburg, VA · On-site

... projects from start to finish, including contracting, needs assessment, project management ... Food and Drug Administration (FDA) as they apply to the Ambassador Program Understand ...

Omnicom

Ambassador Manager

Williamsburg, VA · On-site

... projects from start to finish, including contracting, needs assessment, project management ... Food and Drug Administration (FDA) as they apply to the Ambassador Program * Understand ...

Zimmer, Inc.

Inventory Control Coordinator

Norfolk, VA

$18.50 - $23.25/hr

All these activities are conducted in an FDA regulated and ISO 13485 certified environment. This ... special projects. * May interact with external customer contacts * May be questioned and/or ...

Omnicom

Senior Writer

Williamsburg, VA · On-site

... projects such as web, display ads, email, and other online user experiences Understand brand strategy, marketing goals, and U.S. Food and Drug Administration (FDA) legal and regulatory requirements ...

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Showing results 1-20

All JobsFda Project JobsFda Project Jobs in Hampton, VA

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 Hampton, VA are hiring for Fda Project jobs?

Cities near Hampton, VA with the most Fda Project job openings:

Fda Project jobs near you

Project Manager

Instant Systems Inc

Norfolk, VA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 4 days ago

Job description

As the Project Manager (PM), you will work to coordinate various Engineering and Facilities related projects. The PM drives company goals by ensuring projects are delivered on time, within scope, within budget, and in compliance. The PM finds creative solutions, collaborates across cross-functional teams, and looks for ways to make a difference by implementing and improving systems that support timely completion of projects.

Responsibilities:

    • Effectively coordinate and collaborate with the following cross functional teams:
      • Engineering
      • R & D
      • Production
      • Quality Systems
      • Regulatory Affairs
      • Supply Chain
      • Client Services
    • Lead end-to-end project management for new product development, process improvements, and manufacturing scale-up.
    • Define project scope, goals, milestones, and deliverables in alignment with strategic priorities..
    • Develop and maintain detailed project plans, timelines, and resource allocation strategies.
    • Coordinate cross-functional project teams to ensure alignment and timely execution & resolving team level issues that arise.
    • Manage changing priorities and evolving project requirements, adapting quickly to complex or ambiguous situations to ensure projects stay on schedule and meet objectives.
    • Ensure compliance with medical device regulations (e.g., FDA, ISO 13485, ISO 9001) throughout the project lifecycle.
    • Monitor and track project performance, proactively identifying risks and implementing mitigation strategies.
    • Manage budgets, costs, and resource planning to achieve financial and operational targets.
    • Lead regular project reviews and present progress updates to leadership.
    • Maintain strong communication with stakeholders to ensure alignment on objectives, timelines, and deliverables.
    • Drive continuous improvement in project execution, documentation, and process efficiency.
      • Other Responsibilities as assigned.

To be considered you’ll need:

  • a Bachelors Degree in a scientific field
  • PMP (preferred)
  • 4+ years of experience in project management ideally within product development, manufacturing, or a regulated industry
  • excellent organizational, time management and problem solving skills
  • knowledge of quality systems, CAPA, and continuous improvement methodologies (Lean, Six Sigma)
  • ability to manage multiple projects in a fast-paced, high variability & regulated environment
  • solid company-centric ideology.
  • core values of honesty and respect.
  • a thirst for learning.
  • the desire to be challenged.

You will thrive if you:

  • enjoy an autonomous work environment.
  • have a LEAN mindset.
  • are the first person to help.
  • seek out opportunities to bring added value.

Company Benefits & Perks

  • 401K
  • Health Benefits: Medical, Dental, Vision
  • Wellness Program
  • Life Insurance
  • Corporate Sponsored Events
  • Skill growth opportunities
  • Short Term Disability
  • Ability to Advance
  • Working with energetic & creative problem solvers
  • A mission worthy of your energy and expertise

Applicants for this position must successfully pass background, drug screen and reference check. It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

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