北京招聘

Responsibilities include:

• Develop and execute the Regulatory Affairs strategy to ensure successful product registration and licence extensions in China.

• Develop submission documentation and follow-up type testing to secure medical device approval based on the new NMPA regulations and guidance.

• Independently draft product technical requirements, overview data and research data.

• Develop submission documentation and follow-up type testing for license extension projects, ensuring that product certification extensions are secured before the license expiration date.

• Maintain excellent communication between external authorities (including CMDE and NMPA) and regional/global stakeholders, accurately conveying information.
• Collaborate closely with the local test centre and functional groups within Cochlear headquarters to manage medical device type testing, including electrical safety and EMC testing, to obtain qualified test reports in a timely fashion.

• Support the follow-up and closure of Corrective and Preventive Actions (CAPA) in consultation with the Recipient Services and Operations Team.

• Report all AE and Recall to related government departments in a timely manner.

• Review and maintain Chinese labels and IFU as well as liaisons with manufacturers and distribution centres.
• Assure all marketing, sales and other materials and practices are in conformance with regulatory requirements.

You Bring Your Skills and Experience

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 skills and experience:

Essential:

• Tertiary qualifications in a relevant discipline: electroacoustic, electronic engineering, biomedical engineering

• At least 3-6 years of professional experience in Regulatory Affairs with an ability to demonstrate the following:

  • Solid knowledge and understanding of the new medical device regulations brought in since October 2014.

  • Proven experience in the management, compilation, submission and maintenance of regulatory documentation for new product registrations and license extensions

  • Good understanding of clinical trial regulations

• Excellent verbal and written communication in Mandarin and English languages

• Collaborative mindset and team player with a demonstrated ability to work across culturally diverse stakeholders, including local (China) and regional (Sydney) locations.

Ideal:

• Experience in multinational companies

• Budget and forecasting experience

In turn, you will have the unique opportunity to work in a multinational organization engaged in delivering life changing technology. As you manage regulatory affairs for China, you will be able to share in the excitement of bringing new technologies to market and seeing the profound impact that it has in the lives of the hearing impaired.

Working for Cochlear:

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 live

How to Apply:

Please submit your resume and a covering letter detailing your suitability for this role. All applications will be considered, and qualified candidates will be contacted.

Cochlear Limited is the leading global expert in implantable hearing solutions. For more than 30 years Cochlear has helped over 450,000 people connect to the world of sound. With a global team of over 2,800 passionate experts, Cochlear is an organisation you can be proud to work for. Our people say making a difference in the lives of others is the number one reason they enjoy working at Cochlear.

With a range of solutions for different types of hearing loss, Cochlear maintains the industry’s largest investment in R&D. To improve our products and services we currently work in collaboration with over 100 research partners based in 20 countries.

Cochlear’s mission of “Hear now. And always” embodies our commitment to providing life-time support. To build a sustainable global business, we are continually strengthening our internal capability and infrastructure, through the development of our people, processes and systems. As we continue to launch new products and services, our employees experience growth, change and opportunity right across the business.

Joining the Cochlear team would see you collaborating with dedicated colleagues who share Cochlear’s core values of customer satisfaction, mutual respect, continuous improvement and innovation, performance and professionalism. Whatever career you chose at Cochlear, you will find the work interesting, challenging and rewarding.

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