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Associate Director, Medical Device Industrialization Braine-l'Alleud Belgium,
Posted on : 21 March 2017
- We put our heart, soul and skills into making a difference for people living with severe disease.
- Working together to push the boundaries, we blend the best of our talents to unlock innovation.
- Will you join us in our pioneering adventure?
- To strengthen our Medical Devices Team, we are looking to fill the position of Associate Director, Medical Device Industrialization
Nature and scope:
- This role is focused on the technical industrialization of drug delivery technologies and other medical devices for company s chemical and biological medicines pipeline.
- This work will be performed in the context of cross-functional technical program teams that ensure the design, development, industrialization, and life cycle management of medical device programs to meet the needs of internal stakeholders and ultimately patients.
- Within the context of these teams, the role can alternately be a contributor focused on medical device industrialization topics or the program leader ensuring all aspects of the program. Importantly, although the role is focused on industrialization activities, it is not restricted solely to these considerations.
- Anticipating and challenging the full scope of program activities (and receiving challenges from other team members) is expected and encouraged.
- As a senior position within the Devices, this role is expected to take leadership duties within the program teams in managing the interface with external partners, assessing and controlling the budgetary and timeline implications for industrialization activities, ensuring compliance with the medical device Quality Management System, and ensuring that all intellectual property arising in the course of programs is appropriately protected.
- As a program leader, these same considerations apply but the scope of activity is extended to all aspects of the program.
- Coordination of the technical industrialization of drug delivery and other medical devices in the frame of cross-functional technical program teams
- Project management of medical device industrialization activities performed internally or by external partners, potentially including the management of industrialization contracts and supplier agreements
- Assessment and control of budgets and timelines relating to industrialization activities within program teams, particularly in relation to external partners
- Project planning and tracking as well as anticipation of total program challenges within program teams
- Preparation, justification, and strategic planning of industrialization, validation, commercial launch planning, and life cycle management planning within program teams and contribution to respective regulatory submissions
- As Program Leader, accountability for the project management of the full scope of design, development, industrialization, and life cycle management of a program, extending the focus on industrialization to all aspects of the program.
- Preparation of conceptual design and proposal of new strategic programs, including translation of internal customer requirements into realistic product and program requirements.
- Evaluation of new devices and technologies to supplement existing platforms or to propose new programs
- Ensuring compliance with the medical device Quality Management System in the context of programs (either as contributor or leader) and HS&E requirements
- Ensuring protection of all intellectual property that may arise from programs (either as contributor or leader)
Education and skills:
- Proven track record in project management, medical device development, industrialization, and production
- Pharmaceutical business experience and familiarity with competitive landscape of devices and pharmaceuticals, drug development process, health economics and health outcomes
- Knowledge of Good Manufacturing Practice (e.g. Eudralex vol 4, 21.CFR 210 and 211, ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations in the field of medical devices and mobile health, including human factors engineering
- Project management skills in planning, tracking, controlling, anticipating, challenging projects
- Proven track record in managing and leading internal and external project teams
- Leadership of internal and external project teams
- Experience in evaluating external projects and technologies
- Experience in integrating medical device activities with the needs of regulatory submissions
- Experience in budget and financial management
- Experience in intellectual property management including design and patent procedures and processes
- Experience in managing and negotiating contracts and agreements
- HS&E processes and procedures
- Leading and influencing cross-functional and matrix teams
- Motivation, empowerment of teams and leading by example
- Management of external relationships
- Program advocacy, negotiation (internal and external) and conflict resolution
- Written and oral presentation skills
- PhD or Master's degree preferred
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Braine L'alleud Belgium
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