Associate Director, Digital
hace 2 semanas
**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 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
- 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**:
- ** Education & core experience**
- Healthcare degree (e.g. RN, MD, MBBS) with at least three years of clinical experience post-registration, maintaining registration
- University degree or equivalent qualification in a relevant scientific discipline, with at least six years of 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
- 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/co-ordination
- Ability to influence without authority
- Open to multiple perspectives
- Balanced perspective
- Solution-focused
- 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
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