Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

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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