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Project Manager
2 months ago
Acara Solutions has been providing our staffing related services to advanced manufacturing firms for 65 years. Our Plymouth, MN medical device manufacturing client has a need for a Project Manager with European Union medical device regulatory experience. This is a contract position that is expected to last at least 6 months. Contract-to-direct is always a possibility. The position is onsite in Plymouth with some hybrid work schedule flexibility.
This is a Type III implantable medical device.
The product has already received EU approval. The PM will be responsible for project management of regulation procedural updates, approval steps, documentation…
Plans and directs schedules. Monitors the program/project from initiation through delivery, interfacing with customers on process, regulation interpretation, technical matters, and integration into the Quality System. Drives completion of the project to deliver on schedule. Present program strategies and updates to executive management and stakeholders.
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Plans and directs schedules
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Monitors the program/project from initiation through delivery, interfacing with customers on process, regulation interpretation, technical matters, and integration into the Quality System
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Drives completion of the program/project to deliver on schedule
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Present program strategies and updates to executive management and stakeholders
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Work with Labeling, Operations, Quality and Supply Chain and possibly other departments
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Collect, communicate, and ensure data accuracy in reporting project deliverable status
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Provide direction on regulation ensuring accurate understanding and interpretation of requirements and their impact
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Drive deliverables schedule based on established plans
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Create and deliver project status report-outs (PowerPoint, Memo's, meetings, etc.)
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Effectively deliver and adjust messaging across all levels of the organization
Required Skills / Qualifications:
Bachelor's degree (ideally in engineering, life sciences or industrial technology or similar)
Min 5 years of experience in a project manager role
Min 5 years of experience in medical device industry
Min 2 years of European Union regulatory affairs experience
Preferred Skills / Qualifications:
PMP Cert
