**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)LI-JB1LI-Onsite**Beware of scams online or from individuals claiming to represent Convatec****Equal opportunities**Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.**Notice to Agency and Search Firm Representatives****Already a Convatec employee?
