Design Project Manager
Jacksonville, FL · On-site
The Design Project Manager will lead multidisciplinary design teams in delivering innovative ... Ensure all designs meet applicable codes, standards, and industry regulations, including GMP, FDA ...
Design Project Manager
Jacksonville, FL · On-site
The Design Project Manager will lead multidisciplinary design teams in delivering innovative ... Ensure all designs meet applicable codes, standards, and industry regulations, including GMP, FDA ...
Project Manager
Odessa, FL · On-site
Knowledge of packaging machinery regulatory standards (FDA, ISO, CE Mark) a plus. * Familiarity with Lean manufacturing a plus. * PMP, PRINCE2, or other project management certifications are a plus.
Project Manager
Odessa, FL · On-site
Knowledge of packaging machinery regulatory standards (FDA, ISO, CE Mark) a plus. * Familiarity with Lean manufacturing a plus. * PMP, PRINCE2, or other project management certifications are a plus.
Project Manager
Odessa, FL · On-site
Knowledge of packaging machinery regulatory standards (FDA, ISO, CE Mark) a plus. * Familiarity with Lean manufacturing a plus. * PMP, PRINCE2, or other project management certifications are a plus.
Project Manager
Odessa, FL · On-site
Knowledge of packaging machinery regulatory standards (FDA, ISO, CE Mark) a plus. * Familiarity with Lean manufacturing a plus. * PMP, PRINCE2, or other project management certifications are a plus.
Design Project Manager
Jacksonville, FL · On-site
The Design Project Manager will lead multidisciplinary design teams in delivering innovative ... Ensure all designs meet applicable codes, standards, and industry regulations, including GMP, FDA ...
Design Project Manager
Jacksonville, FL · On-site
The Design Project Manager will lead multidisciplinary design teams in delivering innovative ... Ensure all designs meet applicable codes, standards, and industry regulations, including GMP, FDA ...
Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred. * Strong communication skills and accountability to project deliverable timing and budgets required.
Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred. * Strong communication skills and accountability to project deliverable timing and budgets required.
Project Manager
Odessa, FL · On-site
Knowledge of packaging machinery regulatory standards (FDA, ISO, CE Mark) a plus. * Familiarity with Lean manufacturing a plus. * PMP, PRINCE2, or other project management certifications are a plus.
Project Manager
Odessa, FL · On-site
Knowledge of packaging machinery regulatory standards (FDA, ISO, CE Mark) a plus. * Familiarity with Lean manufacturing a plus. * PMP, PRINCE2, or other project management certifications are a plus.
Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred. * Strong communication skills and accountability to project deliverable timing and budgets required.
Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred. * Strong communication skills and accountability to project deliverable timing and budgets required.
Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred. * Strong communication skills and accountability to project deliverable timing and budgets required.
Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred. * Strong communication skills and accountability to project deliverable timing and budgets required.
Maintain timelines, action item lists, and all necessary documentation for design control per FDA ... Maintain project design history files in accordance with regulatory requirement * Performs other ...
Maintain timelines, action item lists, and all necessary documentation for design control per FDA ... Maintain project design history files in accordance with regulatory requirement * Performs other ...
Maintain timelines, action item lists, and all necessary documentation for design control per FDA ... Maintain project design history files in accordance with regulatory requirement * Performs other ...
Maintain timelines, action item lists, and all necessary documentation for design control per FDA ... Maintain project design history files in accordance with regulatory requirement * Performs other ...
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Fractional Operations Project Coordinator-Human Factors/Medical Device
Dunedin, FL · On-site
$40 - $75/hr
Administrative Project Support: Maintain study timelines, track vendor deliverables, and ensure all ... 62366, FDA guidance, or IRB protocols is a major plus). * Exceptional vendor management and ...
Quick apply
Be Seen First
Fractional Operations Project Coordinator-Human Factors/Medical Device
Dunedin, FL · On-site
$40 - $75/hr
Administrative Project Support: Maintain study timelines, track vendor deliverables, and ensure all ... 62366, FDA guidance, or IRB protocols is a major plus). * Exceptional vendor management and ...
... to project deadlines. * Ensures corporate policies and procedures are in full compliance with regulatory obligations. * Serves as liaison with the FDA, company personnel, corporate partners, and ...
... to project deadlines. * Ensures corporate policies and procedures are in full compliance with regulatory obligations. * Serves as liaison with the FDA, company personnel, corporate partners, and ...
Balance multiple projects. Step-in to fill-in/take over ongoing projects with minimal notice. * The minimum compliance expectation for this role entails strict adherence to FDA regulations and ...
Quick apply
Balance multiple projects. Step-in to fill-in/take over ongoing projects with minimal notice. * The minimum compliance expectation for this role entails strict adherence to FDA regulations and ...
Clinical Project Coordinator
Miami, FL · On-site
To support project management in the completion of allocated projects to the agreed standards of ... FDA. If you indicate you are under the age of 18 or have been debarred then your application will ...
Clinical Project Coordinator
Miami, FL · On-site
To support project management in the completion of allocated projects to the agreed standards of ... FDA. If you indicate you are under the age of 18 or have been debarred then your application will ...
Project Manager, R&D
Palm Beach Gardens, FL · On-site
$120K - $165K/yr
Lead teams in defining project strategies, establishing goals, and ensuring project scope is ... Familiarity with FDA regulatory pathways (e.g., 510(k), combination products). * Proven ability to ...
Project Manager, R&D
Palm Beach Gardens, FL · On-site
$120K - $165K/yr
Lead teams in defining project strategies, establishing goals, and ensuring project scope is ... Familiarity with FDA regulatory pathways (e.g., 510(k), combination products). * Proven ability to ...
Project Manager, R&D
Palm Beach Gardens, FL · On-site
$120K - $165K/yr
Lead teams in defining project strategies, establishing goals, and ensuring project scope is ... Familiarity with FDA regulatory pathways (e.g., 510(k), combination products). * Proven ability to ...
Project Manager, R&D
Palm Beach Gardens, FL · On-site
$120K - $165K/yr
Lead teams in defining project strategies, establishing goals, and ensuring project scope is ... Familiarity with FDA regulatory pathways (e.g., 510(k), combination products). * Proven ability to ...
This role coordinates and submits regulatory reports to FDA and Country/Regional competent ... Assists with continuous improvement activities and/or special projects, as assigned. * Assists in ...
This role coordinates and submits regulatory reports to FDA and Country/Regional competent ... Assists with continuous improvement activities and/or special projects, as assigned. * Assists in ...
QA PM Specialist
Gainesville, FL · On-site
This role coordinates and submits regulatory reports to FDA and Country/Regional competent ... Assists with continuous improvement activities and/or special projects, as assigned. * Assists in ...
QA PM Specialist
Gainesville, FL · On-site
This role coordinates and submits regulatory reports to FDA and Country/Regional competent ... Assists with continuous improvement activities and/or special projects, as assigned. * Assists in ...
Perform testing as needed to generate data for method validations and other special projects ... Work in a regulated environment (FDA, EPA, etc.) is preferred, but not required Compliance ...
Perform testing as needed to generate data for method validations and other special projects ... Work in a regulated environment (FDA, EPA, etc.) is preferred, but not required Compliance ...
Regulatory Manager
Sunrise, FL · On-site
Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre ... Review, edit and provide regulatory and quality system approval for project documentation. Review ...
Regulatory Manager
Sunrise, FL · On-site
Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre ... Review, edit and provide regulatory and quality system approval for project documentation. Review ...
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 is the difference between Fda Project vs Fda Reviewer?
| 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.
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 cities in Florida are hiring for Fda Project jobs? Cities in Florida with the most Fda Project job openings:
Full-time
Re-posted 18 days ago
Job description
Company Description
CRB's over 1,100 expert professionals drive innovative, life-changing and life-saving solutions for manufacturers in the life sciences and food and beverage industries. Our mission, vision, and core values put client satisfaction and employee experience at the center of everything we do.
As an AEC Firm we proudly specialize in industries that inherently carry important social responsibility - we recognize our impact and influence in the communities we serve and pursue corporate responsibility through the lens of people, community, and planet. From oncology and rare disorders to COVID-19 or alternative proteins, our design and construction projects are pioneering solutions addressing important issues such as food scarcity and global health.
Job Description
The Design Project Manager will lead multidisciplinary design teams in delivering innovative, compliant, and efficient facility solutions for clients in the life sciences, biotechnology, and pharmaceutical sectors. This role is pivotal in ensuring design excellence, client satisfaction, and seamless integration between architecture, engineering, and construction.
Responsibilities
Qualifications
Minimum Qualifications
Additional Qualifications
Additional Information
All your information will be kept confidential according to EEO guidelines.
CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening.
CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails.
CRB offers a complete and competitive benefit package designed to meet individual and family needs.
If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.
CRB's over 1,100 expert professionals drive innovative, life-changing and life-saving solutions for manufacturers in the life sciences and food and beverage industries. Our mission, vision, and core values put client satisfaction and employee experience at the center of everything we do.
As an AEC Firm we proudly specialize in industries that inherently carry important social responsibility - we recognize our impact and influence in the communities we serve and pursue corporate responsibility through the lens of people, community, and planet. From oncology and rare disorders to COVID-19 or alternative proteins, our design and construction projects are pioneering solutions addressing important issues such as food scarcity and global health.
Job Description
The Design Project Manager will lead multidisciplinary design teams in delivering innovative, compliant, and efficient facility solutions for clients in the life sciences, biotechnology, and pharmaceutical sectors. This role is pivotal in ensuring design excellence, client satisfaction, and seamless integration between architecture, engineering, and construction.
Responsibilities
- Project Leadership: Manage the design phase of complex facility projects from concept through construction documentation, ensuring alignment with client goals, regulatory requirements, and CRB's quality standards.
- Client Engagement: Serve as the primary design liaison with clients, facilitating clear communication, managing expectations, and ensuring satisfaction throughout the project lifecycle.
- Team Coordination: Lead and coordinate internal design teams (architects, engineers, consultants) and external partners to deliver integrated solutions on schedule and within budget.
- Scope & Budget Management: Define project scope, develop design budgets, and monitor progress to ensure financial and operational targets are met.
- Regulatory Compliance: Ensure all designs meet applicable codes, standards, and industry regulations, including GMP, FDA, and EU Annex 1 requirements.
- Innovation & Sustainability: Promote the use of cutting-edge technologies and sustainable design practices, including CFD modeling, energy-efficient systems, and modular construction strategies.
- Risk Management: Identify design risks early and implement mitigation strategies to avoid delays or cost overruns.
Qualifications
Minimum Qualifications
- Bachelor's or Master's degree in Architecture, Engineering, or related field.
- 7+ years of experience in design project management, preferably in pharmaceutical or biotech facility design.
- Strong understanding of GMP, cleanroom design, and regulatory environments.
- Proven ability to lead cross-functional teams and manage multiple projects simultaneously.
- Excellent communication, negotiation, and organizational skills.
- Proficiency in design software (Bluebeam, Navisworks) and project management platforms.
Additional Qualifications
- PMP or similar project management certification.
- Familiarity with progressive contracting and integrated project delivery (IPD) models.
Additional Information
All your information will be kept confidential according to EEO guidelines.
CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening.
CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails.
CRB offers a complete and competitive benefit package designed to meet individual and family needs.
If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.