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Regulatory Affairs Program Manager

Job No: 609346
Department: Cochlear Limited - Sydney
Work type: Permanent
Location: Sydney
Recruitment Contact: Renai Larkin

Cochlear’s mission is to help people hear and be heard. Around the world, more people choose a Cochlear-branded hearing 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. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always.

We have an exciting opportunity for an experienced project manager to join our global regulatory team. Accountable for managing, monitoring and reporting on the plan for the group product pipeline strategy, the Program Manager Regulatory Affairs role enables the execution of the product pipeline strategic plan, with critical pro-active escalation and guidance through any risks to the pipeline strategy.  

Key Responsibilities:

  • Development and maintenance of the regulatory plan for product certification and re-certification
  • Project management of the product certification pipeline and re-certifications so that all products are certified on time, and any key risks with plan execution are pro-actively managed and communicated.
  • Project Management and Execution
  • Building and Fostering Relationships and Managing Stakeholders

What you will gain from this opportunity:

  • Diverse interaction with people across the entire organisation.
  • Gain an in-depth understanding and be part of the solution of the business drivers for the Company’s vision.

 Key Requirements:

  • Degree in Project Management or equivalent.
  • Effective interpersonal, written and oral communication with various levels of stakeholders across the business.
  • Experience in influencing and motivating virtual teams with diverse skills to achieve outcomes.
  • Very broad project management experience preferably in medical devices. Track record for successful delivery of projects on time, budget and quality.
  • Experience managing multi-discipline projects, cross divisional teams comprising of technical and non-technical professionals.
  • Ability to work independently with limited guidance.
  • Experience working in a team-oriented, collaborative environment.
  • Demonstrated excellent stakeholder management skills
  • Strong analytical and problem-solving abilities.

Ideal:

  • Knowledge of  Quality or Regulatory Affairs
  • Knowledge of the development and manufacture of medical devices.
  • Experienced in managing projects involving the development of medical devices in a medically regulated environment preferred.
  • Experience in defining the project scope.
  • Formal qualifications / accreditation in Project Management (e.g. PMP)

Take the first step towards a career with Cochlear; a career you can be proud of.

 

Application close: AUS Eastern Daylight Time

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