Associate Director, Digital - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

Typical Accountabilities, what you will be doing:

Provide and be responsible for the medical and scientific input to the device and/or digital program's design and development
Contribute to developing clinical device and/or digital documents, such as hazard assesssments, in collaboration with the Device & Digital Safety Physicians.
Review, analyse and interpret safety data obtained to support device and digital development in collaboration with the Device & Digital Safety Physicians.
Responsible for device safety activities associated with combination products, supporting the Patient Safety Therapeutic Product teams with device regulatory requirements
Perform duties as Medical Device Surveillance Leader for complex and/or multiple products.
Take accountability and lead resolution of safety issues and mediate crossfunctional agreement related to assigned medical devices or digital assets.
Participate in crossfunctional process improvement or other initiatives related to digital and devices on behalf of the Patient Safety organisation.
Contribute to the generation of Patient Safety's position on innovative use of digital health solutions and medical devices in medicinal product development and post market activities
Support individual PS TA's project/product teams with their implementation and use of digital and devices in association with their assigned AZ medicinal project/product
Responsible for the Patient Safety Device, Digital and Diagnostic SharePoint site, including contribution and delivery to consultation requests
Support AZ compliance with medical device, device constituent and digital health regulatory and legal requirements, including implementation of new regulatory & legal requirements.

Education, Qualifications, Skills and Experience:

Essential:

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Education & core experience

Healthcare degree (e.g. RN, MD, MBBS) with at least three years of clinical experience postregistration, maintaining registration
University degree or equivalent qualification in a relevant scientific discipline, with at least six years of medical device/device constituent experience and postgraduate training to your support ability to approve clinical documents
Knowledge and understanding of global medical device and digital health requirements and an ability to balance this with industry standards to achieve business goals
Excellent written and verbal English
Experience of leadership of a team as a project leader
Ability to manage multiple stakeholders
Extensive knowledge in project management skills, specifically leading teams
Demonstrated excellent skills in: written and verbal communication
Able to work with high degree of autonomy
Able to represent AstraZeneca externally where required
Key capabilities:
Understanding of governance processes
Process improvement (e.g. Lean methodology)
Collaboration/coordination
Ability to influence without authority
Open to multiple perspectives
Balanced perspective
Solutionfocused
Experience with inspection activities

Desirable:

University degree or equivalent qualification in relevant scientific field, with at least five years relevant experience
PhD in scientific field or Engineering degree
Experience of being nominated as Person Responsible for regulatory Compliance as defined in the EU Medical Device Regulation (Regulation (EU) 2017/745)
Line management experience