招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
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. 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.
Cochlear is the global market leader in implantable hearing solutions and is a top 100 company on the ASX. Our implantable hearing devices include cochlear implant systems (CI) and bone anchored hearing aids (Baha?). Cochlear Asia-Pacific, the fastest growing division of Cochlear Ltd, has a direct market presence in Japan, Korea, China, India, SE Asia and Australia/NZ to work with surgeons and clinics to grow the market for implantable hearing solutions.
Key Responsibilities
We are seeking a Regulatory Affairs Manager, to join our team in China at our Beijing office. Reporting to the General Manager, this role is responsible for Regulatory Affairs in China, and works as part of a global team.
In this role you will be responsible for ensuring that products and services for Cochlear can be bought to market in an accelerated timeframe, and ensuring there is full management visibility on any regulatory or trade barriers that may prevent this from occurring.
Key Requirements
The successful applicant for this role will be able to display:
*Demonstrated experience leading a regulatory function, ideally working with class III or IV medical devices
*Alternatively in the pharmaceutical industry
*Knowledge of China Medical Device Law and the product registration process
*10+ years` experience in regulatory affairs including experience interacting directly with Regulatory Agencies and external providers in order to meet designated timeframes and maintain regulatory compliance
*Demonstrated experience in managing regulatory affairs tasks for preparation, implementation and execution of submissions within designated timeframes
*Ability to work effectively as part of a national leadership team, imparting your knowledge and sharing successes with others
*Team management experience, with proven experience in supporting the development and driving performance of your team
*Business level Mandarin writing and reading, and high level of verbal
*Business level English writing, reading and verbal
*High level attention to detail, ensuring information is managed or actioned correctly
*Demonstrated project management experience
Working for Cochlear:
Cochlear pioneered and is the global leader in the research and development, manufacture and marketing of implantable hearing solutions. Cochlear’s global headquarters is located on the campus of Macquarie University, Sydney, Australia to enable links to world leading hearing science research. A success story in the commercialisation of R&D, Cochlear has a 70% share of the global market, employs more than 2,500 people worldwide, operates directly in over 20 countries and sells in over 100 countries. Over 250,000 people across more than 100 countries now experience hearing as a recipient of a Cochlear hearing solution. Cochlear can offer:
The Work - A high impact job supporting world leading technology
The Organisation – A global leader in active implantable medical device hearing technology
The Opportunity – To make a difference to the quality of people’s lives
As a world-leader in innovative medical devices, Cochlear encourages continuous learning for employees. Visit www.cochlearcareers.com for more information.
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