Vice President Regulatory Pipeline Strategy

Cochlear is the global market leader in implant hearing solutions. Cochlear's mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It’s an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear.The OpportunityThis pivotal role presents the opportunity to influence the future product and technology roadmap for Cochlear globally. Reporting to the Vice President Global Quality & Regulatory and leading a team of experienced regulatory professionals, the Vice President Regulatory Pipeline Strategy is responsible for ensuring appropriate regulatory strategies are developed to bring new products and services to market, as well as ensuring approved products already on market continue to meet all regulatory and compliance requirements. Within its global remit, this position is also responsible for ensuring regulatory processes are well defined and enacted and drive alignment and improvements to deliver efficiencies and scalability.Other key responsibilities include:

• Ensure regulatory strategies are aligned to support the overall business strategy and regulatory inputs and guidance are provided to support the Product Innovation Process (PIP)
• Ensure post approval commitments are understood and strategies are in place to support market expansions
• Ensure effective Regulatory Intelligence processes are in place
• Staying abreast of latest trends, developments, and changes in quality and regulatory environments, assess and communicate their impact and implication to the organization
• Lead development of compliant Labelling and Instructions for Use
• Drive operational excellence while ensuring processes are compliant and supports business growth
• Develop and maintain relationships with key internal and external stakeholders and partners (such as Notified bodies, Health Authorities & Regulators) to support the achievement of pipeline goals
• Lead a culture of achievement and one team by role modelling Cochlear’s HEAR behaviours.
• Build capability of team, by attracting, developing, and retaining talent, to deliver on current and future business goals

About You

• Strong leadership experience within a global medical device manufacturer, with a track record of successful product approvals – experience with Class III technologies and combination devices highly regarded
• Comprehensive understanding of global medical device regulations, with the ability to apply this knowledge effectively
• Experience in integrating regulatory and clinical strategies to bring new technologies to market

• Experience in building, developing, and managing global regulatory teams
• Excellent communication skills with the ability to build effective stakeholder partnerships across enterprise and externally
• An ability to think strategically and develop plans that drive current and future organizational success
• Ability to deal with ambiguity and complexity when making decisions
• Degree level qualifications (e.g. Degree in Engineering, Science) with demonstrated successful experience in regulatory affairs

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.If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.#CochlearCareersHow we recognise your contributionWe 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.comAt 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.