Project Manager job in Muscatine
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Muscatine CorTech LLC
| Job Ref: | 350532 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 100.00-120.00/Per Hour |
| Remote: | No |
Location |
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| City: | Muscatine |
| Post Code: | 52761 |
| Map: |
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Description |
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Jobsrus.com is seeking a Project Manager who is highly organized, detail oriented, and a great communicator. A Project Manager Engineer in the context of the FDA (U.S. Food and Drug Administration) typically works in highly regulated industries such as pharmaceuticals, medical devices, biotechnology, or food manufacturing. Their primary responsibility is to manage projects related to regulatory compliance, quality control, and product development in accordance with FDA regulations. Here is a job description for a Project Manager Engineer with a focus on FDA-related responsibilities: Job Title: FDA Project Manager Engineer Job Overview: The Project Manager is responsible for planning, executing, and overseeing projects related to regulatory compliance, quality assurance, and product development in alignment with FDA guidelines and regulations. This role requires a strong understanding of FDA requirements and processes, project management expertise, and the ability to work in regulated environments. Key Responsibilities: Regulatory Compliance: Stay up-to-date with FDA regulations and guidelines relevant to the industry (pharmaceuticals, medical devices, biotechnology, etc.). Ensure that all projects adhere to FDA compliance requirements throughout their lifecycle. Develop and maintain comprehensive knowledge of regulatory submissions, including 510(k) applications, Investigational New Drug (IND) applications, New Drug Applications (NDA), etc. Project Planning: Define project scope, objectives, and deliverables while considering FDA regulations. Develop project plans, timelines, and resource allocation to achieve regulatory compliance and product development goals. Identify and assess project risks and develop risk mitigation strategies, especially those related to FDA submissions. Cross-Functional Collaboration: Collaborate with cross-functional teams, including R&D, quality assurance, regulatory affairs, and manufacturing, to ensure alignment with FDA requirements. Coordinate and communicate project progress, issues, and priorities to stakeholders. Quality Assurance: Implement and oversee quality assurance processes to ensure compliance with FDA regulations. Conduct internal audits to identify and address compliance gaps. Documentation and Reporting: Maintain comprehensive and accurate project documentation, including FDA submissions, test reports, and regulatory documentation. Prepare and submit regulatory documents and reports to the FDA in accordance with established timelines. Risk Management: Implement risk management processes to assess and mitigate risks associated with FDA compliance and regulatory submissions. Budget and Resource Management: Manage project budgets and allocate resources effectively. Monitor project costs and ensure projects are executed within budget constraints. Change Control: Implement change control processes to ensure that changes in project scope or requirements are managed in compliance with FDA regulations. Qualifications: Bachelor's or Master's degree in engineering, preferably in a field related to the industry Strong knowledge of FDA regulations and guidelines relevant to the specific industry. Project management certification (e.g., PMP) is a plus. Proven experience in project management, particularly in FDA-regulated environments. Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Proficiency in project management software and tools. | |
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