Director Regulatory Operations

2 hours ago

Sydney, New South Wales, Australia Cochlear Full time $120,000 - $180,000 per year

The Opportunity

Cochlear has a newly created opportunity for a
Director, Regulatory Operations
. In this role, the successful Director will lead multiple global teams to define and deliver scalable and efficient regulatory operations and processes, support international registration planning and fulfilment, oversee technical communications and localisation activities, and drive technology adoption to enhance operational effectiveness.

Responsibilities include:

  • Lead and manage regulatory operations teams across technical domains and geographies.
  • Drive scalable processes and governance for regulatory and technical communications.
  • Oversee international registration planning and fulfilment for global markets.
  • Define strategy and drive change and transformation

What makes this opportunity unique?

This is a unique opportunity for an experienced people leader to drive meaningful transformation in a global regulatory operations function. The role offers the chance to lead a large, complex team and influence how Cochlear delivers regulatory support across international markets. It's well-suited to leaders with strong collaboration and influencing skills. As a member of the global regulatory leadership team, the Director Regulatory Operations position will play a pivotal role in shaping and executing strategic changes that improve efficiency, scalability, and service delivery across the organisation.

About You

To add value to Cochlear in this role, you'll be able to demonstrate the following essential skills and experience:

  • Degree in Engineering, Science or Technology.
  • Minimum 10 years' experience in the Medical Device industry.
  • Strong understanding of EU MDR, FDA and ISO13485 requirements.
  • Proven ability to lead global teams and drive operational excellence.
  • Experience managing complex projects across multiple disciplines.
  • Exceptional communication, analytical and planning skills.
  • Ability to influence and negotiate effectively.

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