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APS 5 Unique Device Identification (UDI) Engagement Officer

APS 5 Unique Device Identification(UDI) Engagement Officer
Position Details
Section Responsibilities
Our client is responsible for complex monitoring, analysis investigation and review activities for post market regulatory programs for medical devices. They are also responsible for the post market activities of medical devices, including in vitro diagnostic medical devices (IVDs), and monitoring them throughout their lifecycle to ensure they continue to meet appropriate standards.
Position Description
Areas of Responsibility
The APS 5 UDI Engagement Officer is responsible for supporting the APS 6 (UDI Support Manager) in the technical functions required to support the UDI project from design to production.
This is a customer facing role (both internal and external stakeholders) with touch points on enquiries management, IT systems and business process design.
Key Duties
Support stakeholders in the UDI implementation – which includes the early adopter projects, the sandpit and the production environment. Including:  

  • Monitor inbox/Instant Chat/and answer telephone enquiries, to resolve and respond to stakeholder enquiries.
  • Promptly escalate complex stakeholder enquiries to achieve timely resolution for stakeholders.
  • Creation of new user access profiles.
  • Work with the UDI Support Manager to establish and update Standard Operating Procedures and process documentation.
  • Engage with subject matter experts to complete/refine business process and associated documentation as needed.
  • Create and updating support and guidance materials, including the FAQs, web content, user guides, help desk self-help content.

Work with the UDI project team and other Departmental staff to define specific aspects, including:  

  • Define technical (specifically IT and subject matter expert) support roles and responsibilities.
  • Quality assurance of the Business Continuity Plan.
  • Support the UDI and Engagement teams define the approach to onboarding manufacturers, sponsors, and agents, including scoping of legal requirements and approval process to move from sandpit into production.
  • Assist in establishing business process approach to onboarding staff in sandpit and production environments.
  • Other duties as required.

Start Date
Length of Contract
12 months
Our preferred candidate will possess:  

  • Sound judgment, attention to detail and organisational skills and ability to take responsibility for work, prioritising tasks and producing quality outputs to meet tight deadlines.
  • Proven ability to provide high-quality stakeholder/ customer service within a specific timeframe.
  • Proven experience working within system support.
  • A flexible attitude, understanding that priorities may change with short notice.
  • The ability to manage competing priorities.

Mandatory skills:  

  • Strong communication skills including ability to prepare clearly articulated written work on the subject matter, targeted towards specific audiences.
  • Demonstrated ability to work within a customer/stakeholder focused environment.
  • Ability to apply problem solving skills to resolve customer enquiries.
  • Ability to quickly grasp complex concepts and regulatory requirements.
  • Experience in a project environment and working within a high performing team which is a blend of permanent staff, contractors, and external suppliers.
  • Experience in managing a team including training, BAU and change management activities.

The below skills are highly desirable:  

  • Experience working in a regulatory environment (especially with Therapeutic products and/or Medical Devices).
  • Experience supporting implementation of a new system in a stakeholder support/ enquiries management capacity.
  • Involvement with project planning or support is highly desirable.

If interested, please apply directly through the links provided. Alternately, contact Kalpana Palaniyappa for more information.

Kalpana Palaniyappa
0403 200 666  

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