Project Manager I
8 hours ago
Blue Star Partners LLC is seeking a skilled Project Manager I to oversee the activities and personnel involved in small to large-scale projects. The ideal candidate will have a strong understanding of clinicals, design controls, and regulated environments, as well as experience working with cross-functional teams in science, lab, or clinical environments.
Key Responsibilities:
- Direct the activities and personnel associated with small to large-scale projects, focusing on non-IT business applications and disciplines.
- Manage all facets of single or multiple multidimensional projects through the Full Project Life Cycle.
- Collaborate with project sponsors, business units, and users to identify project scope and focus, develop project initiatives, and implement project requirements, plans, processes, and tools.
- Assign, guide, and monitor project staff, ensuring the successful execution of project tasks.
- Deliver high-quality project solutions to business problems within defined budgets and timelines.
- Provide expert project guidance and support proactively throughout the project completion.
- Provide tracking, reporting, and presentations to management and users.
- Demonstrate experience with medical devices and a strong understanding of clinicals, design controls, and regulated environments.
- Lead cross-functional teams in science, lab, or clinical environments, leveraging excellent interpersonal skills and negotiation abilities.
- Support IVDR compliance activities including the creation of technical files, post-market surveillance activities, and new product development documentation.
- Perform on-market support tasks such as regulatory impact assessments and regulatory operations including BUDI number updates, label reviews, FDA laser reports, and state manufacturing licenses.
Requirements:
- Bachelor's degree in a relevant field.
- PMP certification required.
- 1-6 years of experience in project management.
- Experience with medical devices and working with cross-functional teams in science, lab, or clinical environments.
- Excellent interpersonal skills and the ability to negotiate effectively with team members.
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Project Manager I
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Santa Clara, California, United States Blue Star Partners LLC Full timeJob Title: Project Manager IBlue Star Partners LLC is seeking a highly skilled Project Manager I to oversee the activities and personnel involved in small to large-scale projects, with a primary focus on non-IT business applications and disciplines.Scope of Services:The Project Manager I will be responsible for managing all aspects of single or multiple...
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Santa Clara, California, United States Blue Star Partners LLC Full time{"h1": "Project Manager I Job Description", "p": "At Blue Star Partners LLC, we are seeking a highly skilled Project Manager I to oversee the activities and personnel involved in small to large-scale projects. The successful candidate will have a strong understanding of clinicals, design controls, and regulated environments, as well as experience working...
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