Associate Director, Medical Device Clinical
hace 1 semana
The Associate Director, Medical Device Clinical Evaluation and Investigation, will lead the gap analysis of AstraZeneca clinical proceudres against relevant regulations and standards.
The role sits in the Device & Digital Safety Centre of Excellence, within Global Patient Safety - Operations, Technology & Analytics and Chief Medical Office.
The Associate Director, Medical Device Clinical Evaluation and Investigation responsibilities includes but is not limited to completing gap assessments against medical device clinical standards/regulations, support device teams will clinical evaluation and investigation questions and collaborating with process owners to uplift Astrazenea procedures.
Typical Accountabilities
Clinical Evaluation & Investigation Specific
- Complete gap assessment of AstraZeneca procedures against medical device clinical standards and regulatiosn
- Responsible for the lifecycle management of assigned Patient Safety processes related to clinical evaluation and investigation
- Partner with functions who own procedures relevant to medical device clinical evaluation and investigation to support their updates in line with regulations and standards
- Partner with clinical system counterparts to ensure data collection and reporting is aligned to regulations and standards.
General
- Demonstrate and contributes to a culture of "ownership" and efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/partner engagement.
- Support the oversight of medical device regulations and local requirements that impact Patient Safety and/or require implementation
- Serve as the delegate, where appropriate, for the Director, Device & Digital Safety
- Support the allocation of and contribution to digital, device and diagnostic consultation requests of Patient Safety
- Partner with License Agreement & Contracts where medical devices are involved
- Ensure customer requirements are understood, critically evaluated, prioritised and addressed within the area. Work with Line Managers and Leadership to prioritise the needs and resources required to deliver these requirements, and provide feedback and clear rationale for any areas that will not be addressed.
- Ensures that internal processes are fit for purpose and maximise the effectiveness of the outsourced delivery, working with relevant partners to improve processes.
- Partner with system counterparts to ensure an integrated and holistic approach to processes and systems.
- Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers
- Establish a global mindset to systematically gather, consolidate & communicate regulatory authority and industry intelligence for the proactive continuous improvement of activities required to ensure license to operate and regulatory compliance
- Participate in projects to agreed targets and provide expert operational and/or strategic regulatory or pharmacovigilance input and guidance in crossfunctional teams.
In partnership with peers (Other Nominated Area Leads) establish, champion and facilitate a top tier partnership relationship with the outsource provider.
Education, Qualifications, Skills and Experience
Essential
- University degree or equivalent qualification in relevant scientific field, with relevant experience
- three years, Bachelors
- At least two year's professional experience in clinical or quality management systems relating to medical devices and device constituents
- Experience from design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes within the area of focus for role.
- Experience from authoring standards documents (Standard Operating procedures)
- Experience from development and provision of training through virtual meetings and other media
- Experience in outsourcing and partnership with external vendors
- Knowledge in project management skills, specifically leading teams
- Demonstrated excellent skills in: written and verbal communication
- Able to work with a 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
- Knowledge of new and developing medical device expectations
- Experie
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