Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.

The Opportunity

Cochlear has a newly created opportunity for a Regulatory Affairs Manager for Combination Products. The successful candidate will be the regulatory Subject Matter Expert (SME) for drug/device combination products and support the development of Cochlear’s knowledge base, systems and processes for designing and manufacturing these products. You will have the opportunity to work in a global capacity to identify regulatory requirements and advise cross-functional and cross-regional project teams of these requirements, provide ongoing regulatory support to the product design teams, sustaining engineering and manufacturing groups through assessing the regulatory filing requirements for product and process changes as well as providing regulatory advice on required verification & validation documentation and changes required to quality procedures.

Responsibilities include:

• Coordinating the development of corporate regulatory strategies and plans for device-led combination products in collaboration with regional and country Regulatory Affairs and other corporate functions.
• Liaising with regional and in-country Regulatory Affairs to identify and assess regulatory requirements for the design, manufacture and use of device-led combination products.
• Defining documentation requirements for regulatory submissions and working with product development teams.
• Developing, introducing and maintaining Common Technical Documentation (CTD).
• Leading activities at Cochlear Global headquarters that identify, develop and prepare information required to support and execute pre-submission meetings with regulators and competent authorities as well as external consultants in key markets.
• Reviewing and assessing the regulatory impact of changes, and non-conformances across the entire supply chain.
• Leading the implementation and improvement of systems and processes to improve deliverables.

What makes this opportunity unique?        

In this global role, the Regulatory Affairs Manager for Combination Products will have the opportunity to work across organisational and geographical boundaries, contributing to the development of global processes that meet everchanging regulatory requirements. The successful candidate will have the ability to make a tangible difference to people’s lives and contribute to Cochlear’s growth story in a direct way as you drive the technical excellence and quality design of pioneering products.

About You. As we grow our operations, we are looking for people who share our passion for delivering quality hearing solutions to our customers. To add value to Cochlear in this role, you'll be able to demonstrate the following essential skills and experience:

Minimum

• Degree in Engineering, Science or Technology.
• Minimum 7+ years regulatory experience with medical devices, pharma or combination products.
• 3-5 years regulatory experience with device-led combination products (e.g., drug eluting stents and pacing leads).
• Demonstrated knowledge/experience in the following areas:
  • Practical understanding of regulations associated with the product development and approval processes for device-led combination products.
  • Managing Regulatory Affairs tasks for the preparation, implementation, and execution of submissions.
• Advanced regulatory writing skills (preparation of submissions, CTDs).
• Excellent communication and influencing skills with experience in working with and negotiating with regulators.
• Comfort with ambiguity.

How we recognise your contribution

We want Cochlear to be a place where our people truly enjoy coming to work. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported.  Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.

For more information about life at Cochlear, visit www.cochlearcareers.com

At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We're open to a conversation about what flexibility means for you.