... FDA-regulated initiatives ... Provide technical and management leadership across major project tasks, driving innovation and ...
Quick apply
... FDA-regulated initiatives ... Provide technical and management leadership across major project tasks, driving innovation and ...
Quick apply
... FDA-regulated initiatives ... Provide technical and management leadership across major project tasks, driving innovation and ...
Charlotte, NC ยท On-site
$81K - $107K/yr
Liaising with clients, suppliers, contractors, and relevant regulatory bodies (e.g., FDA) * Project management within cost and time constrained environments * Sets up systems for the troubleshooting ...
Charlotte, NC ยท On-site
$81K - $107K/yr
Liaising with clients, suppliers, contractors, and relevant regulatory bodies (e.g., FDA) * Project management within cost and time constrained environments * Sets up systems for the troubleshooting ...
Richmond, VA ยท On-site
Project Engineer Location: Richmond, VA. Duration: Longterm Job Summary: Project Engineer role ... The role requires strong experience in pharma or FDA-regulated environments with GMP knowledge and ...
Quick apply
Richmond, VA ยท On-site
Project Engineer Location: Richmond, VA. Duration: Longterm Job Summary: Project Engineer role ... The role requires strong experience in pharma or FDA-regulated environments with GMP knowledge and ...
... FDA-regulated initiatives ... Provide technical and management leadership across major project tasks, driving innovation and ...
... FDA-regulated initiatives ... Provide technical and management leadership across major project tasks, driving innovation and ...
Gaithersburg, MD ยท Hybrid
$124K - $155K/yr
Recent FDA-related experience is required. This is a hybrid position, which includes a3-day on-site ... Leverage tools such asJIRA,Confluence, and other project management or data analytics tools to ...
Gaithersburg, MD ยท Hybrid
$124K - $155K/yr
Recent FDA-related experience is required. This is a hybrid position, which includes a3-day on-site ... Leverage tools such asJIRA,Confluence, and other project management or data analytics tools to ...
Be Seen First
Philadelphia, PA ยท Remote
$80 - $120/hr
The ideal candidate will serve as a project manager, strategic thought leader and hands-on project lead, driving complex FDA regulatory programs from initiation through resolution. You will own ...
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Be Seen First
Philadelphia, PA ยท Remote
$80 - $120/hr
The ideal candidate will serve as a project manager, strategic thought leader and hands-on project lead, driving complex FDA regulatory programs from initiation through resolution. You will own ...
Falls Church, VA ยท Hybrid
$124K - $155K/yr
Recent FDA-related experience is required. This is a hybrid position, which includes a3-day on-site ... Leverage tools such asJIRA,Confluence, and other project management or data analytics tools to ...
Falls Church, VA ยท Hybrid
$124K - $155K/yr
Recent FDA-related experience is required. This is a hybrid position, which includes a3-day on-site ... Leverage tools such asJIRA,Confluence, and other project management or data analytics tools to ...
Nashville, TN ยท On-site
Write overall project quality (validation scope) plans and validation summary reports. * Organize, guide, and write requirement specifications. * Oversee, execute and review qualification ...
Nashville, TN ยท On-site
Write overall project quality (validation scope) plans and validation summary reports. * Organize, guide, and write requirement specifications. * Oversee, execute and review qualification ...
This role will manage complex cross-functional projects in an FDA-regulated environment and partner with teams including R&D, Quality, Regulatory, Operations, Supply Chain, Marketing, and Medical ...
This role will manage complex cross-functional projects in an FDA-regulated environment and partner with teams including R&D, Quality, Regulatory, Operations, Supply Chain, Marketing, and Medical ...
Redwood City, CA ยท On-site
$211K - $264K/yr
Familiar with FDA's Project Optimus guidance. * Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology. * Hands-on experience with ...
Redwood City, CA ยท On-site
$211K - $264K/yr
Familiar with FDA's Project Optimus guidance. * Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology. * Hands-on experience with ...
Auburn, NY ยท On-site
$114K - $146K/yr
Support compliance with FDA, PMO, SQF, OSHA, environmental regulations, and company standards. * Assist in identifying and mitigating process risks that could impact product quality or food safety.
Quick apply
Auburn, NY ยท On-site
$114K - $146K/yr
Support compliance with FDA, PMO, SQF, OSHA, environmental regulations, and company standards. * Assist in identifying and mitigating process risks that could impact product quality or food safety.
Auburn, NY ยท On-site
$114K - $146K/yr
Support compliance with FDA, PMO, SQF, OSHA, environmental regulations, and company standards. * Assist in identifying and mitigating process risks that could impact product quality or food safety.
Auburn, NY ยท On-site
$114K - $146K/yr
Support compliance with FDA, PMO, SQF, OSHA, environmental regulations, and company standards. * Assist in identifying and mitigating process risks that could impact product quality or food safety.
Write overall project quality (validation scope) plans and validation summary reports. * Organize, guide, and write requirement specifications. * Oversee, execute and review qualification ...
Write overall project quality (validation scope) plans and validation summary reports. * Organize, guide, and write requirement specifications. * Oversee, execute and review qualification ...
Auburn, NY ยท On-site
$114K - $146K/yr
Support compliance with FDA, PMO, SQF, OSHA, environmental regulations, and company standards. * Assist in identifying and mitigating process risks that could impact product quality or food safety.
Auburn, NY ยท On-site
$114K - $146K/yr
Support compliance with FDA, PMO, SQF, OSHA, environmental regulations, and company standards. * Assist in identifying and mitigating process risks that could impact product quality or food safety.
Boulder, CO ยท On-site
Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. * Oversee execution ... Present project status updates and KPI reporting to senior leadership and stakeholders. Qualified ...
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Boulder, CO ยท On-site
Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. * Oversee execution ... Present project status updates and KPI reporting to senior leadership and stakeholders. Qualified ...
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 ...
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 ...
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 ...
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 ...
Ensure GMP, FDA, and quality compliance. Required Qualifications * Experience leading engineering projects in pharmaceutical or FDA-regulated environments. * Strong knowledge of GMP and CAPEX project ...
Quick apply
Ensure GMP, FDA, and quality compliance. Required Qualifications * Experience leading engineering projects in pharmaceutical or FDA-regulated environments. * Strong knowledge of GMP and CAPEX project ...
Danvers, MA ยท On-site
Experience supporting FDA regulated products * Project Management Professional (PMP) Certification * Experience working with Agile development with a Continuous Discovery/Delivery mindset
Quick apply
Danvers, MA ยท On-site
Experience supporting FDA regulated products * Project Management Professional (PMP) Certification * Experience working with Agile development with a Continuous Discovery/Delivery mindset
La Verne, CA ยท 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
Quick apply
La Verne, CA ยท 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
| Aspect | Fda Project | Fda Reviewer |
|---|---|---|
| Required Credentials | Typically requires a background in life sciences, engineering, or related fields; often includes project management certifications | Requires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience |
| Work Environment | Project teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firms | Regulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions |
| Employer & Industry Usage | Used in project management contexts to oversee regulatory submissions and compliance | Used 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.

Rockville, MD โข On-site
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 4 days ago
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
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 3โappraised 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
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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It services
51 - 200 Employees
Rockville, MD, US
2003