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Fda Project Jobs in Florida (NOW HIRING)

Pharmaworks LLC

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.

Baxter

Project Manager, R&D

Palm Beach Gardens, FL

$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 ...

FORMULATED Solutions LLC

CHEMIST III

Largo, FL · On-site

Execute method qualification and transfer studies to support new product introductions and customer projects. * Ensure analytical methods comply with USP, FDA, ICH, and internal quality requirements.

FORMULATED Solutions LLC

CHEMIST III

Largo, FL · On-site

Execute method qualification and transfer studies to support new product introductions and customer projects. * Ensure analytical methods comply with USP, FDA, ICH, and internal quality requirements.

Open Scientific

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 ...

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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?

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 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 are popular job titles related to Fda Project jobs in Florida? For Fda Project jobs in Florida, the most frequently searched job titles are:
What job categories do people searching Fda Project jobs in Florida look for? The top searched job categories for Fda Project jobs in Florida are:
What cities in Florida are hiring for Fda Project jobs? Cities in Florida with the most Fda Project job openings:
Fda Project jobs near you
Project Manager

Project Manager

Pharmaworks LLC

Odessa, FL • On-site

Full-time

Posted 7 days ago

Job description

Continue Your Career as a Project Manager in a Growing Company!

At ProMach, we’re looking for people who want to shine. You’ll have opportunities to take your career in the direction you desire.

You’ll be challenged and rewarded. Improve our customers’ packaging performance and efficiency every day. Help build the future of packaging automation. We’re proud of that and hope you will be too.

Do we have your attention? Keep reading.

As a Project Manager, you’ll take ownership of the entire project lifecycle—planning, design, manufacturing, assembly, testing, and financial reporting—while ensuring projects are delivered on time, within budget, and to the highest quality standards. You’ll play a critical role in maintaining strong customer relationships and support continuous improvement across our operations.

What You'll Do?

  • Develop and manage detailed project plans, including scheduling, resource allocation, and risk mitigation within Smartsheet.
  • Serve as the primary customer contact, providing regular updates, addressing concerns, and ensuring expectations are met or exceeded.
  • Coordinate across engineering, manufacturing, finance, and other teams to ensure smooth project execution.
  • Work with the Director of Operations and PM team to develop processes/tools, to improve efficiencies within the PMO group.
  • Monitor quality and ensure deliverables meet both customer requirements and internal standards.
  • Track and report project performance, including costs, forecasts, and progress updates.
  • Proactively identify risks and implement mitigation strategies.
  • Lead project closeout activities, including final documentation, lessons learned, and customer feedback.
  • Manage Leadtime and Budgets for assigned projects to a successful execution.

What We're Looking For?

  • Bachelor’s degree in mechanical engineering, Electrical Engineering, or related field.
  • 1 to 3 years of proven experience managing multiple, complex capital equipment projects in a fast-paced environment.
  • Engineering to Order experience a plus.
  • Hands-on experience with commissioning and troubleshooting industrial automation or packaging machinery.
  • Strong ability to interpret technical drawings, specifications, and financial data.
  • Proficiency with Smartsheet, ERP systems, Excel, and other project management tools.
  • Excellent problem-solving and decision-making skills, with a drive for continuous improvement.
  • Strong communication skills to foster collaboration, accountability, and innovation.
  • 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.

There's no monopoly on good ideas or limits to how far you can advance with our team. We offer an open, communicative environment that fosters individual initiative. We pride ourselves in being a company where people choose to build a career.

In addition to growth opportunities, as a ProMach employee, you receive more than just a paycheck. Total compensation includes your salary, comprehensive medical/dental/vision programs, as well as life insurance, a generous paid time off program, and a retirement savings plan with a company match. And because we understand the importance of feeling protected, there is no waiting period for benefits – you are eligible on your first day of employment!

Please note that the pay ranges listed on external job boards, outside of our posting details, do not accurately reflect our internal compensation ranges.

Pro Mach, Inc.

We have been named to the Inc. 5,000 list of fastest growing private companies in the U.S. seven times. We continue to introduce innovative products, enter new markets, expand our global presence, and actively acquire new capabilities.

We have the rewards, opportunities, and the market strengths of a large organization combined with the entrepreneurial culture of a small, fast-paced company. You will enjoy the benefits of working with a growing company that competes globally with the personal touch and feel of a smaller company where you can make an impact every day.

Pharmaworks

Pharmaworks manufactures innovative blister packaging systems for the pharmaceutical, consumer goods, and contract packaging industries. With a robust and flexible lineup of thermoforming solutions that spans from stand-alone machines to turnkey blister packaging lines, Pharmaworks can handle nearly any customer challenge with unmatched precision to meet even the most stringent requirements. Pharmaworks is a product brand of ProMach, a global leader in packaging line solutions. As part of the ProMach Pharma business line, Pharmaworks helps our customers protect their reputation and grow the trust of their consumers.

Curious about life at ProMach? Follow us on LinkedIn, Twitter, and Instagram!

More career opportunities to consider!

ProMach is an Equal Opportunity Employer. Pro Mach uses E-Verify to verify employment eligibility of all new hires to work in the United States. Pro Mach is a drug-free workplace.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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