The Associate Director, 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 Associate Director, 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 safety and clinical subject matter expertise to 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 use of 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 with at least one year of clinical experience post-registration, maintaining registration 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 

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we follow the science with curiosity and courage. Our commitment to Oncology is driven by our ambition to eliminate cancer as a cause of death. With cutting-edge science fused with the latest technology, we aim for breakthroughs that transform medicine. Our collaborative research environment unites academia and industry, expediting research in some of the hardest-to-treat cancers. Join us to build a rewarding career dedicated to improving millions of lives.

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Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.