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Group Head of Regulatory Pipeline Strategy

Apply now Job no: 609238
Work type: Permanent
Location: Sydney
Categories: Oceania, People Manager, Quality & Regulatory

Cochlear develops world-leading medical devices that help people hear. As the top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.

We are recruiting for an exciting innovative role in our Regulatory department to lead as a Group Head of Regulatory Pipeline Strategy. This is a newly created position as we expand our Regulatory team. You will be tasked to lead the regulatory product innovation strategy working closely with R&D and ensure the timely approval of implant, sound processor and acoustics products for markets regulated by the TGA, FDA and TUV, through leadership of the Regulatory market access team and ensuring business cross-functional partnership and alignment.

Key Responsibilities

The purpose of the Group Head of Regulatory Pipeline Strategy role is to ensure a high performance culture and build the capability of the Regualtory Market Access team. In order to be successful candidate for this role you will need an Ensure the planning and operational alignment of the team’s processes and systems to enable delivery of product approval.

In this role you will be responsible for:

  • Lead and coach the team to actively participate and provide regulatory input and advice for Cochlear’s Product Innovation Process (PIP)
  • Planning and directing multiple strategic projects with highest criticality including prioritizing and selecting appropriate projects to present recommendations to CLTD functional leaders and Regional Regulatory teams
  • Developing, implementing and optimising systems to track reports, regulatory submissions and other post marketing commitments, so that the team and key stakeholders are able to plan for and monitor activity related to upcoming registrations
  • Creating a robust strategic talent development and succession planning in alignment with functional growth strategies within the CLTD RA organization

Key Requirements

  • Bachelor's degree in related field with related experience in Regulatory Affairs required and skill levels exceeding the requirements of the Director; Master’s degree in related field preferred
  • Knowledge of at least two medical device jurisdictions e.g FDA, TGA EU MDR
  • Demonstrated ability to lead  teams, provide coaching and feedback for high performance and growth, and experience partnering with People and Culture on all aspects of employee engagement
  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
  • Ideally, have the ability to negotiate and influence to deliver optimal commercial outcomes with RAPs certification

To express your interest in this role, please submit your application to be reviewed by our P&C TA team.  All successful candidates will be contacted.

Advertised: AUS Eastern Daylight Time
Applications close: AUS Eastern Daylight Time

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