Back to jobs

Project Manager – Devices Vigilance Policy

Job description

Overview


  • Contract role
  • Competitive rates
  • Inclusive and high performing team

Key Responsibilities

The Project Manager duties may include but are not limited to the following:
  • Development of a risk based assessment framework in relation to surface texture for breast implants.
  • Reinvigoration of the Action Plan Consumer Working Group to co-design consumer friendly documents which translate technical regulatory language into plain English to make documents more accessible to non-expert audiences.
  • Support establishment of a separate Women’s Health Working Group.
  • Support the post-market enhancements projects as required.
 
Tasks
  • Analyse and review the Breast Implant Working Group papers and clinical evidence.
  • Undertake research and work closely with Executive Level Officers and other internal stakeholders as required, on resolution of questions concerning the projects and working groups.
  • Assist in drafting option papers as required to consider what could/should be implemented for:
          • Internal consultation;
          • Targeted consultation with RegTech and selected industry/consumer groups; and
          • Consider consequences for industry, HCP, consumers (if any)
  • Liaise with external stakeholders as required to invite new working group members or refresh existing members.
  • Assist in preparing meeting papers, briefings and organise meetings, conflict of interest registers.
  • Draft minutes and Communiques.
  • Build relationships with consumer bodies and state and territories.
  • Liaise with web publishing, regulatory education/guidance team to develop/draft external facing documents and consumer friendly artefacts.
  • Undertake coordination and administration and other tasks as required, e.g. ad hoc briefing requests, development of educational materials.