Regulatory and Quality Manager - Taiwan
Job no: 613989
Work type: Permanent
Categories: Quality & Regulatory, Asia Pacific, Individual Contributor
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 people to Hear Now. And Always.
Cochlear Asia-Pacific, the fastest growing division of Cochlear Ltd, has a direct market presence in Japan, Korea, China, India, SE Asia and Australia & New Zealand. Cochlear conducts most of its leading research, development and manufacturing of cochlear implants in the Asia Pacific region with state-of-the-art manufacturing facilities in Australia and repair facilities in Malaysia. We are building a new facility in Chengdu to serve China and emerging markets and increase global production.
Cochlear now has a new opportunity for a RA &QA Manager to be based in our Taiwan office. In this role, the successful candidate will have the ability to manage RA regulatory compliance and registration submissions, quality management, and reimbursement in Taiwan.
Responsibilities include but not limited to:
- Provide professional opinions/answers for local RA and NHI questions
- Develop regulatory strategy for registration of new products and product changes
- Manage submission dossier from local for new products to TFDA/NHI/NCC.
- Help for NHI code submission and provide strategy on behalf of Cochlear.
- Submit/transfer new product license on behalf of Cochlear
- Maintain existing product licenses, QSD and upload UDI.
- Implement trial protocols, data collection and reporting.
- Validate new market product releases and competitor regulation/ NHI code update.
- Conducting market/ Competitive study and provide research support.
- Ensure compliance to advertisement regulations for promotional and collateral materials for professionals, teachers, parents as required.
- Analyse and review marketing materials, research and clinical papers for RA submission.
- Support translation projects of clinical and marketing materials.
- Provide to Cochlear HK team, documentation for product listing and registration, as required.
- Provide to Cochlear HK team, regulatory documentation for tenders, as required.
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:
- Bachelor’s degree in engineering, scientific, or healthcare
- Excellent report writing and documentation skills and strong skills in influencing in a matrix team environment
- Ability to manage stakeholders at all levels within the business and work collaboratively in cross functional teams
- Ability to make judgments and provide advice which balances the business interest and regulatory risk. Able to make and be accountable for decisions when faced with ambiguity
- Relationship building skills within matrix team environment
- Ability to apply knowledge of Taiwan regulatory requirements for medical device
- Fluent in Mandarin and business level English
- Prefer 10+ years of Taiwan RA/QA experience and experience for Class II and Class III product submission
In turn, you will have the unique opportunity to be part of growing function in a multinational medical device organisation. This is a new role in China that is expected to grow and develop as regulatory affairs in China changes. Cochlear offers a collaborative work environment with ample support from regional and global stakeholders.
Working for Cochlear:
For 40 years, Cochlear has been creating reliable products that continue to keep people connected to the world and to each other. We help people of all ages to hear in more than 180 countries around the world. Our technology connects people to life's possibilities and to the people who matter most. We have over 4000 employees globally dedicated to improving people's lives. To date, we have Invested over $2bil to date in research and development.
Cochlear can offer:
- The Work - A high impact job supporting world leading technology
- The Organisation – The global leader in implantable medical device hearing technology
- The Opportunity – To make a difference to the quality of people’s lives
Visit www.cochlearcareers.com for more information.
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.
Advertised: Taipei Standard Time
Anticipated Application Closing: Taipei Standard Time
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