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Fda Project Jobs (NOW HIRING)

Albertsons

Process Engineer - Dairy

Boise, ID

Familiarity with dairy regulatory and quality frameworks, including FDA/PMO requirements, HACCP, and internal quality standards * Demonstrated experience optimizing production lines in a regulated or ...

Hitachi

FDA Validation Engineer

Nashville, TN

Write overall project quality (validation scope) plans and validation summary reports. * Organize, guide, and write requirement specifications. * Oversee, execute and review qualification ...

Stereotaxis

Project Manager

Minneapolis, MN · On-site

Ensure all projects comply with FDA, ISO 13485, and other relevant medical device industry regulations and standards. Identify potential project risks and develop mitigation strategies. Conduct ...

Inherent Technologies

Project Engineer

Danvers, MA · On-site

Experience supporting FDA regulated products * Project Management Professional (PMP) Certification * Experience working with Agile development with a Continuous Discovery/Delivery mindset

DRT Strategies, Inc.

Project Manager

Silver Spring, MD · On-site

$90K - $120K/yr

Project Description: In accordance with Executive Order 14293, "Regulatory Relief to Promote ... Engage and coordinate with cross-functional stakeholders across FDA, HHS, and other federal ...

DRT Strategies, Inc.

Project Manager

Silver Spring, MD · On-site

$90K - $120K/yr

Project Description: In accordance with Executive Order 14293, "Regulatory Relief to Promote ... Engage and coordinate with cross-functional stakeholders across FDA, HHS, and other federal ...

Algo Soft Solutions LLC

Project Engineer

Richmond, VA · On-site

Pharma experience or FDA regulated environment, GMP Experience Nice to haves: CAPEX Experience, Site Build Experience Core Responsibilities •      Support execution of assigned project ...

Kaav Inc.

SAP Project Manager-CA

La Verne, CA · Hybrid

The ideal candidate will have extensive experience in SAP S/4HANA upgrade projects , preferably in regulated industries like pharma , ensuring compliance with GxP, FDA, and other regulatory standards

Kaav Inc

SAP Project Manager-CA

La Verne, CA · On-site

The ideal candidate will have extensive experience in SAP S/4HANA upgrade projects , preferably in regulated industries like pharma , ensuring compliance with GxP, FDA, and other regulatory standards

JC Automation Corp

PR · On-site

$40 - $50/hr

Ensure all project activities adhere to cGMP, FDA 21 CFR Part 11, and applicable Quality Practices; support internal audits and regulatory inspections as needed. * Project Documentation & Reporting:

Albertsons

Process Engineer - Dairy

Boise, ID · On-site

Familiarity with dairy regulatory and quality frameworks, including FDA/PMO requirements, HACCP, and internal quality standards * Demonstrated experience optimizing production lines in a regulated or ...

Steuben Foods

Senior Project Engineer

Elma, NY

$100K/yr

D to implement best-in-class engineering solutions aligned with cGMP, HACCP, FDA, and OSHA ... Capital project engineering experience leading $3-$10M projects, with demonstrated success in ...

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Fda Project information

What are the key skills and qualifications needed to thrive as an FDA Project Manager, and why are they important?

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 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 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.

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Fda Project jobs near you
Infographic showing various Fda Project job openings in the United States as of May 2026, with employment types broken down into 2% Internship, 2% As Needed, 25% Full Time, 53% Part Time, and 18% Contract. Highlights an 90% Physical, 1% Hybrid, and 9% Remote job distribution.
Health IT Program Director (FDA Programs)

Health IT Program Director (FDA Programs)

PRECISE SOFTWARE SOLUTIONS INCORPORATED

Rockville, MD • Hybrid

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 16 days ago

Job description

Description

Position Summary

Precise is seeking a visionary and accomplished Program Director to lead our federal health IT initiatives, with a strong emphasis on FDA-regulated programs. This role is critical to driving the success of large-scale, complex portfolios by providing strategic leadership, technical depth, and fostering collaboration across multidisciplinary teams. The ideal candidate will bring a robust engineering background, deep familiarity with FDA systems and standards, and a proven ability to build high-performing teams and trusted client relationships.

Key Responsibilities 

  • Lead the planning, execution, and delivery of large-scale federal health IT programs, with a focus on FDA-regulated initiatives.
  • Provide technical and management leadership across major project tasks, driving innovation and operational excellence.
  • Responsible for the development and execution of federal business development strategies.
  • Influence senior stakeholders and present complex technical concepts in a clear and accessible manner. 
  • Navigate competing priorities and resolve conflicts to maintain alignment and project milestones.
  • Spearhead capture efforts for organic business growth and re-compete contracts.
  • Direct and mentor large, cross-functional teams with varied technical and functional skill sets.
  • Serve as the primary liaison between business stakeholders, technical teams, and federal clients, ensuring alignment with strategic goals and regulatory requirements.
  • Oversee financials, resource allocation, staffing, and vendor coordination to ensure delivery within scope and budget.
  • Build and maintain strong relationships with FDA and other federal health agencies.
  • Identify and mitigate risks proactively, while championing continuous improvement and process optimization.

Requirements

  • 15+ years of progressive experience in IT program/project management, including 8+ years leading large teams and complex portfolios.
  • Extensive experience in FDA-regulated environments.
  • Proven success in leading organizational change, adoption of new technologies, and system modernization.
  • Demonstrated track record of winning federal contracts.
  • Prior leadership in Federal Health IT programs with strong financial acumen to manage multimillion-dollar budgets.
  • Strong engineering foundation (software, systems, biomedical, or related technical discipline).
  • Expertise in Agile methodologies, quality control, and continuous improvement practices.
  • Exceptional interpersonal, negotiation, and communication skills.
  • Demonstrated ability to foster innovation, collaboration, and excellence across teams.
  • Deep understanding of regulatory technology, compliance frameworks, and federal acquisition processes.
  • Active PMP certification required, demonstrating mastery of project management principles, methodologies, and best practices
  • Bachelor's degree in engineering or related technical field required.

ABOUT US

Precise Software Solutions, Inc. is a mission-focused technology services company delivering secure digital platforms, infrastructure, and operational IT services to government organizations. A CMMI Level 3-appraised company, Precise partners with agency technology leaders and solution providers to design, build, operate, and modernize enterprise IT solutions that support critical public missions combining agility, innovation, and performance to deliver measurable results. 


Precise specializes in cloud and hybrid infrastructure, platform engineering, security operations and compliance, application modernization, and data platforms and analytics. The company is known for its agile, delivery-driven approach and innovative engineering practices, applying operational rigor and performance-focused execution to improve system resilience, security, and scalability across complex government environments.


BENEFITS AND PERKS

  • Comprehensive Health Benefits (Medical, Dental and Vision) 
  • Flexible Spending Accounts (FSA) & Health Savings Account (HSA) 
  • Retirement Plan with 4% match and discretionary match at year end
  • Paid Time Off (PTO): 15 days of PTO accrued per year; 7 holidays+ 3 Floating holidays; 2 Innovation days (paid training days)
  • Short Term and Long-Term Disability
  • Paid Parental Leave 
  • Paid Jury Duty leave 
  • Life and AD&D Insurance 
  • Critical Illness Insurance
  • Training and Development 
  • Wellness Incentives & Discount programs
  • Employee Referral Program 
  • Annual Charity Donation Match 
  • Awards and Recognition

Equal Employment Opportunity Statement

Precise Software Solutions is committed to providing a workplace free from discrimination and harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, age, national origin, disability, sexual orientation, gender identity or expression, marital status, genetic information, protected veteran status, or other legally protected status.

We are an inclusive organization and actively promote equality of opportunity for all with the right mix of talent, skills and potential. We expect every member of the Precise community to do their part to cultivate and maintain an environment where everyone has the opportunity to feel included and is afforded the respect and dignity they deserve.

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