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Technical Manager
Ref No.: 18-28226
Location: Raynham, Massachusetts
Position Type:Contract
Start Date: 04/24/2018
• The MDR Registration Technical manager is a critical position responsible for planning and execution of Product Registration Activities
The TM will prepare execution strategies and project plans for the implementation of the MDR.
• Coordinate the alignment and execution of all activities related building the new Technical Documentation and obtaining CE marking in compliance with EU MDR.
• Proactively coordinate cross-functional deliverables from Regulatory, Medical, Clinical, R&D, Restricted Substances, Biocompatibility, PMS and any other functions as needed
Maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
Develop plans using goals and objectives of the project, appropriate related procedures, applicable historical information, and other necessary resources to align projects.
Ensure project plan and schedule are created and maintained. Ensure all interdependencies are captured and accounted for in the overall schedule and resource model.
Dynamic problem solver able to anticipate potential problems and create solutions.
Measure performance and progress of all assigned projects using appropriate tools and techniques. Manage and control changes to the project scope, project schedule, project resources, and project costs to keep the project plan accurate, updated, and reflective of authorized scope, budget and schedule.

• A minimum of a Bachelor s degree is required.
• A minimum of 8 years of related business experience is required
• Ability to work independently, manage complexity and take ownership for deliverables is required.
• Must have Experience in Medical Device Organization.
• A degree in a Business or Engineering/Scientific discipline is preferred
• Experience within the following functions - Engineering, Operations, Regulatory or Research & Development is preferred.
• Extensive Experience of successfully managing complex, cross functional projects is preferred
Experience of managing Projects with team members in several different locations is preferred
Intermediate computer software skills, i.e. Microsoft Office is required • Strong presentation skills - Able to communicate clearly and concisely across all levels of the company is preferred.