Cochlear (ASX: COH) is an iconic Australian company, synonymous for over 35 years with innovation and class leading technology development in implantable hearing solutions.
Cochlear is committed to win in China with significant investment and focus over the coming years. This role is fundamental to support this aspiration and ensure the China product portfolio offers the latest Cochlear technologies and benefits to patients.
Operating with a China focused remit, we are seeking an experienced Regulatory Affairs professional to join our Chengdu Manufacturing business and support the Plant Manager and contribute to the local leadership team. The role is based in Beijing.
Working across pre and post market phases, you will join a nimble, collaborative team providing cross-functional project support, partnering with Technical Communications, Research and Development, Clinical, Sustain and localisation teams to develop documentation and information for regulatory submissions in China.
Central to your success will be your ability to provide regulatory support throughout the lifecycle of Cochlear products manufactured in Cochlear Chengdu, for registration and regulatory compliance in China and international markets.
In addition, the Regulatory Affairs Specialist is responsible for planning and preparing documentation for type testing and submissions in China and drive the submission process until approval and product launch. The role serves as a primary liaison between provincial MPA, China NMPA and the project teams for regulatory inquiries, issue resolution and technical support.
Bachelor’s degree in engineering, science, healthcare; and or 7 + years’ experience in medical device regulatory affairs. You have a strong attention to detail, exceptional communication, report writing and documentation skills and a proven ability to influence in a matrix team environment.
With collaboration central to your overall approach to work, you are familiar with managing stakeholders at all levels and can navigate ambiguity, make judgments, provide advice and balance complex, competing interests.
Strong communication skills in Chinese and English are essential for this role.
What is 100 % necessity for you to success in this role is an open, positive outlook, a growth mindset and a desire to apply your experience and knowledge to the growth and development of our China market
Development Value of this role:
Ability to understand portfolio of products and engage across multiple Cochlear sites
Deep understanding of China business, culture, regulatory process and requirements
Detailed and system level exposure to all product types in the Cochlear portfolio