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Senior Regulatory Affairs Specialist

2 weeks ago

North Ryde, New South Wales, Australia beBee Careers Full time

**Regulatory Affairs Lead Job Description:**

  • This is an exciting opportunity to work closely with the APAC RA Regional Lead and Global PMOs to drive the execution of RA initiatives for our medical device business units.

**Job Objectives:

  • Lead the Special Projects team in ANZ and develop regulatory strategies for all Special Projects.
  • Work collaboratively with country or local franchise RA leaders to execute Special Projects and set up project plans.
  • Be accountable for completing Special Project impact assessments and ensuring timely updates for each RA action.
  • Participate in the APAC RA leadership team and represent ANZ, sharing best practices on Special Project executions.

**Responsibilities:

  • Leading and developing regulatory strategies for all Special Projects, aligning with internal partners across the organisation.
  • Providing prioritisation, capacity management, and efficiency gain options for Special Project Programs in ANZ.
  • Working collaboratively with country or local franchise RA leaders, leading executions of all Special Projects, and setting up project plans with detailed tasks and timelines.

**Qualifications and Experience:

  • Degree and/or post-graduate qualification in Regulatory Affairs, Engineering, Science or related discipline.
  • Minimum 8 years Regulatory Affairs specialist industry experience, with at least 2-3 years in a lead capacity within the medical device industry.
  • Previous experience managing or leading projects, with highly developed engagement, negotiation, influencing, and leadership skills.