Senior RA Specialist

Cochlear is the global market leader in implant hearing solutions. 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. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It’s an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear.

Introduction

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 more people to hear and experience life’s opportunities.

Cochlear Japan: The Japan operations (NCC) is one of Asia Pacific’s longest established operations, with the Tokyo office opening in 1989.  Japan is an ageing country, and the ageing population is growing, leading to a higher incidence of hearing loss in over 65-year-olds. Hearing loss among the elderly is a huge opportunity. Our work in Japan focuses on raising awareness amongst the elderly whilst increasing better access and service to the Paediatric Market.

The Opportunity

We are seeking a Sr. Regulatory Affairs Specialist based in Japan, reporting to the Director, Regulatory Affairs / Quality Assurance Japan. In this role, the successful Sr. Regulatory Affairs Specialist will have the opportunity to accelerate products’ approval for Japanese Market by working as project’s member.

Accountability 1:  Regulatory Affairs (Yakuji Shonin)

• Contribute establish and maintain effective project management system of NCC to share RA project relevant information to accelerate product approval.
• Seek the most reasonable way to prepare dossier and response to PMDA’s inquiries while highly compliance level. When the dossier cannot enough data that is required by Japanese authority, risk analysis to submit the dossier without the particular data and convince team member about that plan is strongly required.
• Submission dossier must be prepared for the latest PMDA’s requirements as much as we can know. For potential delay of the submission timing and risk must be analyzed and shared as well as the above item.
• Keeping record about internal/external discussion and others, and good filing according to NCC RQR rules is required.
• Flexibility is welcomed as long as the specialist keeping good compliance level to law and regulation.
• Accuracy of submission dossier is one of key for success.
• Passion to know technology and medical theory is also key element for success.
• Regulatory strategy must be suggested to team based on the listed items here.

Accountability 2:   Reimbursement and Clinical matters

• Flexibility and motivation to lean additional required area such as deeper reimbursement work or Clinical work is required. These will be requested to start learning by NCC RQR Director according to NCC’s situation and discussion to set personal development goal.

Accountability 3:   Quality Management System

• Enough knowledge about QMS for RA product submission work and QMS inspection and reliability inspection work is minimally required.
• Support qualified supervisors according to set procedures are required.
• Motivation to lean about deeper QMS things to establish/improve Quality Management System is required.

Accountability 4:   Business license Maintenance

• Support the maintenance work of license including Foreign Manufacturer Registration. Suggest necessary renewal plan to NCC RQR Director with QA manager.
• Support business license obtain/renewal project. Work with foreign manufacturers for FMR timely in collaboration with QA manager.

Accountability 5:   Others

• Maintain and develop contacts with regional colleagues, business partners, industry associates, regional regulatory bodies and medical society.
• Monitoring government legislation relating to PMDL.

Team Role (Individual contributor):

• Follow relevant quality procedures in order to deliver quality products and services and identify and support the implementation of continuous improvement. Undertake additional quality responsibilities (e.g. audit) when appropriately trained to undertake these responsibilities.
• Contribute ideas on systems and process methods to improve deliverables.
• Work safely, complying with all safety procedures, rules and instructions; and reporting workplace hazards, incidents or injuries to manager.

Key Incumbent requirements:

Minimum:

• Adhere to the principles of code of conduct as a member and representative of Cochlear group
• Interpret correctly Japanese regulation and keep maintaining knowledge. Develop, implement and ensure compliance of relevant SOPs
• Bachelor’s Degree
• 5 years or more of experience in medical device regulatory affairs in Japan (product registration of class III or IV) and its active worker
• Expert knowledge of Japanese Pharmaceutical and Medical Device Law and the product registration process
• Business level English of writing and reading and moderate level of speaking
• High level of Japanese usage to understand legal term and technical terms which is required RA expert.
• Smooth operation of MS Word, PowerPoint, Excel and Visio (+Photoshop, hopefully)
• Reasonable communication skill.
• Motivation to learn new things according to the situation.
• Overseas travel (0-2/year) and domestic travel (0-10/year)

Ideal:

• Willingness to manage the long-term project or project by team, and to resolve the complicated situation/subjects.
• Experience to establish/improvement Quality management system (can be partially).
• Bachler degree of science (pharmacy, engineering and others)
• Business level of English speaking

Development Value of this role:

• Opportunity to learn new area relevant to RA work and expand expertise.
• Opportunity to work in a multinational Australian owned organization
• Share in the excitement of bringing new technologies to market

Region-specific Requirements:

Native level Japanese proficiency

How to apply.

If you are excited about what you have read and would like to be considered for this role then please submit your resumes (English and Japanese) and a covering letter detailing your suitability for this role.

At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We're open to a conversation about what flexibility means for you.

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 more people to hear and experience life’s opportunities.

If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.

#CochlearCareers

How we recognise your contribution

We want Cochlear to be a place where our people truly enjoy coming to work. Through our internal programs and employee benefits, we aim to create an environment where our people will feel value and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.

For more information about Life at Cochlear, visit www.cochlearcareers.com

At Cochlear we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential. We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We're open to a conversation about what flexibility means for you.