**About the role**
Ensure the appropriate planning including key performance indicators, scope, budget, forecast, resources, identify project risks are well handled to good implementation of the change-projects in SEG.
Assure compliant with ISO, FDA, and other current regulatory requirements - following internal procedures.
**Key responsibilities**
- Leads multiple project activities throughout project lifecycle to ensure completion within the defined scope,
- Ensure appropriate management of the following change projects, but not limited:
- Control of project deadlines, budgets and manage activities.
- Create CCR documentation, when needed (be owner).
- Ensure the documentation of process or product changes made follow current regulations.
- Coordinate Runs of 0-series production in cooperation with Development Department and Quality Department
- Ensure adequate level of communication with the team members in MX/DK within relevant departments.
- Provide insights to commercial processes: Request for Proposal (RFP), Scope of Work (SOW).
- Develop, maintain, and modify the project documentation for projects-changes portfolio; to ensure effective implementation.
- Act as DHF coordinator
- when required, following procedures established.
- Support on develop and maintain customized configuration in PDM System to be efficient and secure.
- Support on coordinate changes and updates of design control process.
- Close collaboration with clinical development and operations for specific activities, when required.
**Requirements**:
- Bachelor's degree in business, Science and/or Engineering (or equivalent).
- 3 years' work experience with Project and Portfolio Management, scoping, planning, budgeting, stakeholder management and risk management (required).
- Proven project manager tracking records, ability to lead multiple project and high projects complexity.
- Fully understanding documentation control systems and workflows.
- Experience with product and process validation activities (desirable).
- Knowledge of requirements of FDA's QSR, GMP and ISO 13485 or similar regulations (desirable).
- Understanding / awareness of EU Regulation of Medical Devices 2017/745 (desirable)
- Ability to communicate effectively in English (verbal and written) is essential.
- Knowledge of 3D CAD (optional)
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