Medical Device Development Lead
il y a 1 semaine
Make your mark for patients
We are looking for a
Medical Device Development Lead to join us in our Pipeline Devices organization based in Braine-l'Alleud, Belgium.
About the role:
You will focus on leading Medical Device development program(s).
The main objectives of the Program Lead are to:
- lead the design, development, industrialization, and life cycle management of medical device programs for UCB's medicines. The work will be performed in the context of cross-functional technical program teams. Although the role is expected to lead one or more device programs, it can also act as a focused contributor to additional device development. 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 Medical Devices 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.
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 medical device Quality Management System, and ensuring that all intellectual property arising in the course of programs is appropriately protected
- You will take on the leadership of the technical design, development, industrialization and life cycle management of drug delivery and other medical devices in the frame of crossfunctional program teams
- You will oversee the project management of these technical activities performed internally or by external partners, potentially including the management of industrialization and supplier agreements
- You 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 medical devices regulations together with quality principles and techniques.
- You have pharmaceutical and Medical Devices 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, medical device development, 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 medical device 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 specifications
EDUCATIONAL BACKGROUND
- You have a minimum of 1015 years working in the pharmaceutical/biologics/medical device industry. Operational GMP or quality experience would be a distinct advantage
- You have a practical understanding of
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