The Associate Director, Patient Safety Device & Digital contributes to the Patient Safety Device, Digital and Diagnostic process area. The role sits in Global Patient Safety - Operations, Technology & Analytics and Chief Medical Office.
The Associate Director, Patient Safety Processes & Partnerships responsibilities includes but is not limited to providing leadership to the device, digital and diagnostic process area including implementation, communication, compliance, performance and inspection readiness within Patient Safety and Pharmacovigilance.
Key Responsibilities:
Responsible for the lifecycle management assigned Patient Safety processes related to devices, digital and diagnostic.
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, digital health and in-vitro diagnostic 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, digital health or diagnostics 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.
Accountable for being a great partner with supplier(s) providing all external services to the group as appropriate.
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 mind-set 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 cross-functional teams.
In partnership with peers establish, champion and facilitate a top tier partnership relationship with the outsource provider. Includes championing relationship with internal AZ partners and forging strong partnership with all customers/partners. Ensures that all internal and external relationships and interfaces are handled effectively.
Support AZ compliance with medical device, device constituent and digital health regulatory and legal requirements, including implementation of new regulatory & legal requirements.
Requirements:
University degree or equivalent qualification in relevant scientific field.
At least two year's professional experience in patient safety, regulatory affairs or in quality management systems relating to medical devices1 and device constituents.
Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals.
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.
Desirables:
PhD in scientific field.
Knowledge of new and developing regulatory and pharmacovigilance expectations.
Experience of being nominated as Person Responsible for regulatory Compliance as defined in the EU Medical Device Regulation (Regulation (EU) 2017/745).
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