Associate Director, Digital & Devices Safety Scientist
The AssociateDirector, Device & Digital Safety Scientist provides medical and scientific input to device and digital project/products. The role sits in Global Patient Safety - Operations, Technology & Analytics and Chief Medical Office.
The AssociateDirector, Device & Digital Safety Scientist responsibilities include but are not limited to providing support to the development of projects/products involving a device which will require contribution to documents such as hazard assessments and assessing safety data collected.
Accountabilities
Provide ongoing safetyand clinical subject matter expertiseto device and digital projects/products.
Contribute to developing clinical device and/or digital documents, such as hazard assessments or complaint assessments, in collaboration with the Device & Digital Safety Physicians and Associate Directors.
Review, analyse and interpret safety data obtained for device and digital development in collaboration with the Device & Digital Safety Physicians and/or Director Device & Digital Safety.
Support the Director, Device & Digital Safety who leads priority projects/products
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 defined projects/products.
Take accountability and lead resolution of safety issues and mediate cross-functional agreement related to assigned medical devices or digital assets.
Participate in cross-functional 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
Deliver compliance with device constituent and medical device clinical/post market requirements
Support PS TA’s project/product teams with their implementation and useof digital and devices in association with their assigned AZ medicinal project/product
Essential Skills/Experience
Education & core experience
Healthcare degree (e.g.Registered nurse, Respiratory therapist with at least three years of clinical experience post-registration, maintaining registration
or
Healthcare degree (e.g.Registered Nurse, Medical Doctor withat least one yearof clinical experience post-registration, maintainingregistration with two years of industry experience with medical device/device constituent experience
or
University degree or equivalent qualification in a relevant scientific discipline, with at least eight years with medical device/device constituent experience and post-graduate 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
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/co-ordination
Ability to influence without authority
Open to multiple perspectives
Balanced perspective
Solution-focused
Experience with inspection activities
Desirable Skills/Experience
Experience of being nominated as Person Responsible for regulatory Compliance as defined in the EU Medical Device Regulation (Regulation (EU) 2017/745)
Leadership experience, of people or product development
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