As a global leader in implantable hearing solutions, Cochlear has restored hearing for more than 500,000 people of all ages in more than 100 countries. Cochlear was founded in 1981 and is headquartered in Sydney, Australia. Cochlear has offices in more than 20 countries, 5 manufacturing centers and more than 3,000 employees. The annual investment in research is more than $ 120 million.
We are seeking open-minded, business savvy, Clinical Evidence Project Manager in China, reporting to the Director Clinical Evidence-global, to be based in our Beijing office. In this role, the successful candidate will have the opportunity to provide technical expertise, working alongside Cochlear’s regulatory affairs team in mainland China.
This role is responsible for the delivery, technical quality assurance and completion of Clinical Evaluation Reports (CERs) for submission to China’s National Medical Products Administration (NMPA), ensuring that they meet local requirements (including clinical evidence needs) and support the Global Regulatory and Clinical Evidence strategies. As a Clinical Evaluation Subject Matter Expert (SME), the incumbent is the local specialist responsible for managing external stakeholders and providing technical direction to ensure project delivery according to targets.
In addition, the Clinical Evidence Project Manager is responsible for managing an external vendor to develop the CERs, to ensure timely delivery of NMPA-compliant documents, lead clinical evidence evaluation projects and manage key stakeholders to streamline the execution of project, acting as expert for Clinical Evaluation.
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 qualifications, skills and experience:
- Strong written communication and spoken English and Chinese skills.
- Tertiary degree (minimum Bachelor’s degree) in health sciences, nursing, biomedical sciences, pharmacy, pharmacology, or related discipline.
- Ability to manage projects and work cross-functionally.
- Familiarity with, and understanding of, NMPA guidelines as related to clinical evaluation.
- Experience working with vendors.
- Excellent interpersonal and communication skills with internal stakeholders and external customers.
- Strong attention to detail and organizational skills.
- Proficiency in MS Office.
- Flexible and adaptable with the ability to manage ambiguity and complexity.
Development Value of this role:
The successful candidate will contribute to securing the registration of Cochlear’s products in mainland China, helping to refine and define clinical evaluation processes to meet NMPA requirements.
Working for Cochlear:
Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 3,500 people worldwide and invests more than AUD$160 million each year in research and development. Over 550,000 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 Organization – 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.
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.