Medical Device Development Lead > Braine-l'Alleud > Joboolo BE :
Company : UCB Location : Braine-l'Alleud Wallonia From : Talent BE
Although the role is expected to lead one or more device programs, it can also act as a focused contributor to additional devicedevelopment.
Anticipating and challenging the full scope of program activities (and receiving challenges from other team members) is expected and encouraged.You will ensure compliance to MedicalDevices regulations and GMP compliance of Drug/Devices Combination Products from a quality, safety, and efficacy point of view.You will collaborate in matrix program teams with other members of the Devices, Packaging & Wearable Technologies team as well as key internal contacts in Regulatory Affairs, Quality Assurance, Patient Value Supply & Technology Solutions (PVS&TS), and Patient Value Units (PVU), Clinical Team as well our key external partners.You will report to the Pipeline Device Head.What you will do:
As a senior position within the Devices team, you are expected to take leadership duties within the program team in managing the interface with internal stakeholders and external partners, assessing and controlling the budgetary and timeline implications for design, development, industrialization and life cycle management activities, ensuring compliance with the medicaldevice Quality Management System, and ensuring that all intellectual property arising in the course of programs is appropriately protectedYou will take on the leadership of the technical design, development, industrialization and life cycle management of drug delivery and other medicaldevices in the frame of cross-functional program teamsYou will oversee the project management of these technical activities performed internally or by external partners, potentially including the management of industrialization and supplier agreementsYou will take care of project planning, tracking, coordination, and anticipation of challenges, manage all the risk and mitigation plans.You will organize preparation and justification of design verification, design validation, process validation, commercial launch planning, and life cycle management of device programs, including contribution to respective regulatory submissions and when needed interact with Health Authorities.You will take care of the preparation, justification, and strategic planning of industrialization, validation, commercial launch planning.You will undertake evaluation of new devices and technology to supplement existing platforms.For this position you will need the following education, experience and skills:
You have US and EU knowledge of pharmaceutical and medicaldevices regulations together with quality principles and techniques.You have pharmaceutical and MedicalDevices auditing capabilities and skills will be a distinct advantage.You have experience in GMP and Regulatory Requirements within the pharmaceutical industry.You have a proven record of accomplishment in project management, medicaldevicedevelopment, industrialization, and production.You have experience in CAPA management.You can set challenging objectives for self and drive for results using the resources available in an efficient and effective way.
Take accountability for decisions and actions taken.You are proactive, confident, and enthusiastic during the interaction with colleagues during teamwork and take the initiative to promote and share/implement best practices.You must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental and external meetings.
Ensure free flow of information throughout the sphere of work.Your experience in root cause analysis and risk management/assessment skills will be a distinct advantage.You have experience in integrating medicaldevice activities with the needs of regulatory submissions.You have experience in budget management.You have pharmaceutical business experience and familiarity with competitive landscape of devices and pharmaceuticals, drug development process, health economics and health outcomes.You have experience in human factors engineering.You must have demonstrated ability to translate product/service needs into requirements specificationsEDUCATIONAL BACKGROUNDYou have a minimum of 10-15 years working in the pharmaceutical/biologics/medicaldevice industry.
Operational GMP or quality experience would be a distinct advantageYou have a practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirementsYou have a green Belt and/or Project Management certification will be a distinct advantageMANAGEMENT AND LEADERSHIP SKILLS (ability to lead, motivate, inspire, resolve conflict, etc)You must be able to coordinate and lead a team to achieve a desired objective or outcome especially when working in a cross-cultural team environment.
Also needs to be able to share technical competencies through coaching/training team members when appropriateYou can lead and influence cross-functional and matrix teamsYou have some proven negotiation skills and ability to influenceYou must be able to effectively interact with internal and external personnel on many aspects of project and product related matters.
Be confident in providing constructive feedback (and accepting feedback) from work colleagues.
Deal proactively with sub performance of self and others.You are able to cope with stressful situations and drive issue resolution and decisionsYou have excellent planning and organizational skillsDELIVERING SOLUTIONSYou can demonstrate ability to independently analyse data and information to draw conclusions and make effective decisionsYou must be able to identify and assess risks together with proposing corrective actions within area of expertiseYou can help others solve problems in a creative and practical way through development of solutions from innovative problem solving activitiesYou are providing guidance for improvements, corrective and preventive actions related to processesYou must be able to coach staff and colleagues through effective problem solving to ensure the best resolution is obtainedYou must be able to develop (innovative) solutions through judgment and reasoning leveraged from extensive quality experienceAre you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! UCB Braine-l'AlleudWallonia
