• Supporting Cochlear’s growth strategy

• Internal focused role supporting our regional teams

• Work with our product development teams to optimise regulatory paths

Cochlear pioneered and is the global leader in the research and development, manufacture and marketing of implantable hearing solutions. Our global headquarters and manufacturing centre is based in Sydney, Australia.  Today Cochlear has a 70% share of the global market, employs more than 1,900 people worldwide, operates directly in over 20 countries and sells in over 100 countries. Over 180,000 people across more than 100 countries now experience hearing as a recipient of a Cochlear hearing solution.

We are seeking a Regulatory Affairs Professional to join our Quality & Regulatory team at our global headquarters in Sydney. You will have responsibility for implementing regulatory strategies and processes for our portfolio of Cochlear products. A major focus of the role will be achieving regulatory approval for new products, maintaining regulatory licenses for current products and managing continuity of manufacturing licenses.

Key Responsibilities 

• Implement regulatory strategies and processes for medical devices at Cochlear Limited
• Preparation of documentation for Cochlear products in preparation for regulatory submission by the regional regulatory affairs staff in order to obtain regulatory approvals for new products or product/process changes
• Work with Design & Development and Global Marketing departments to ensure timely delivery of effective regulatory submission documentation for new products and product changes
• Manage regulatory submissions of product and process changes with the regions
• Establish and maintain a register of global product submissions including details of submitted documentation to allow effective reference for submission and change management
• Ensure transparency of approved products and product approval plans to the organisation (via intranet etc)
• Develop ongoing relationship with regional regulatory affairs staff to ensure smooth and effective service to the regions
• Support the development of a base of knowledge regarding the regulatory requirements throughout Cochlear’s markets
• Develop guidance documentation and deliver training on regulations and regulatory submission requirements to employees.

Key Requirements

• Experience in Regulatory Affairs
• Clear & effective communicator with well developed report & technical writing skills
• Good computer literacy particularly MS Word, Excel and Powerpoint
• Degree level education (preferably engineering or science)
• Self motivated with demonstrable drive, commitment and achievement orientation - a “can do” attitude
• Regulatory experience in medical device/regulated industry an advantage.

Cochlear can offer you:

• A key role in supporting product development & business growth at Cochlear
• An opportunity to help us deliver on our brand promise of “Hear Now. And always”
• A high impact job - making a difference to the quality of peoples’ lives
• Competitive salary package.