The Executive Level 2 Technical Lead works alongside the Director of the Section, to provide technical expertise and support - lead assessment and / or case management teams in regulatory operations, technical assessment, or projects ensuring high quality outputs as well as providing a strategic level of professional regulatory and technical expertise. The key duties of the position include The EL 2 Technical Lead works alongside the Director of the Section, to provide technical expertise and support - lead assessment and/or case management teams in regulatory operations, technical assessment, or projects ensuring high quality outputs as well as providing a strategic level of professional regulatory and technical expertise. • Build and sustain high performing case management and assessment teams of regulatory and/or technical specialists • As part of the branch and section senior leadership teams, provide operational management and supports for team members coordinating quality and timely premarket reviews of medical devices including escalating and managing issues where required • Collaborating and engaging with internal and external stakeholders (e.g. leading teleconferences and meetings) • Provide specialist technical and regulatory advice for conformity assessment and audit applications, for those applications relating to reforms, and other high profile or high sensitivity matters (e.g. applications that are subject to software, patient matched devices, or borderline products) • Support the programs of regulatory reforms, policy, and continuous operational improvement projects (for example, audit framework, case management model & conformity assessment transformation) • Provide specialist technical and regulatory advice to the Section, Branch and Division as required. • Provide advice to the executive and prepare briefs, ministerial responses and other corporate inputs and communication materials when required. • Represent the TGA on relevant national and international forums, committees and working groups as required • Oversee the development of guidance and technical material relating to Medical Devices • Coach, mentor and empower staff, and support the section through change • Other duties as required and assigned from time to time, including covering for the Director during leave and other absence.
