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.
This is a unique opportunity for an experienced executive to join a global company in a truly influential role. As Head of International Regulatory Affairs and Compliance You will be responsible for the timely approval of implant, sound processor and acoustics products regulated in APAC, Latin America and EMEA markets through leadership of the ROW (Rest of World) market access team. You will have comprehensive knowledge of at least two or more distinct medical device jurisdictions, whilst this opportunity also allows you to partner with the business to ensure cross-functional alignment and inform global strategic direction. This role will also work directly with the regions.
The purpose of the Head of International Regulatory Affairs and Compliance role is to guide, maintain and build sound, productive relationships with global regulatory authorities. These relationships are crucial to the operational success of the business; with a distinct focus on ROW markets you must have an agile and innovative approach to negotiations and problem solving.
In this role you will be responsible for:
- Leading the development of the regulatory approval strategy for implants, sound processors and acoustics products
- Ensuring the planning and operational alignment of the team’s processes and systems to enable timely delivery of product approval
- Fostering a high performance culture to build the capability of the Regulatory Market Access team
- Partner with regions and countries to ensure cochlear complies with all applicable national and international regulatory authorities and regulations globally.
Essential Experience and Knowledge
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 or more medical device jurisdictions e.g, HSA, DCGI, TFDA, ANVISA, RZN etc.
Experience working in a healthcare company, regulatory affairs and medical device required
Experience integrating people, processes and systems within a regulatory function, to deliver business outcomes
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 develop and integrate metrics into the projects and operations that clearly demonstrate the value of regulatory affairs to the business and enable continuous improvement opportunities
Experience partnering with senior leaders in Business Units, Functional Groups, and Regions
Proven record in management, compilation, submission and maintenance of regulatory records
Demonstrated experience in managing regulatory affairs tasks for preparation, implementation and execution of submissions within designated timeframes, including timely responses to agency questions
Experience interacting directly with Regulatory Agencies and external providers in order to meet designated timeframes and maintain regulatory compliance
Ideal Knowledge and Experience
Ability to negotiate and influence to deliver optimal commercial outcomes