Sr. Regulatory Affairs Specialist

Please submit your application as soon as possible, as we reserve the right to close this advertisement at any time.

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 world full of sound. We aim to transform the way people understand and treat hearing loss and innovate to connect people with future technologies. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Learn and grow with us as we tackle the most complex challenges in helping more people to experience a lifetime of hearing.

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.

Why apply for this role?

• Drive regulatory strategy for innovative implantable hearing technologies.
• Lead submissions and compliance activities for the Japanese market.
• Develop cross‑functional expertise across regulatory, reimbursement, and quality systems.

How to Apply

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

Brief Summary

We’re seeking a motivated Sr. Regulatory Affairs Specialist who is eager to play a pivotal role in accelerating access to life‑changing hearing solutions in Japan. This is an opportunity to bring your specialist regulatory knowledge into a collaborative, purpose‑driven environment where your work directly supports people living with hearing loss.

The Opportunity

Cochlear has an opportunity for a full time Permanent Sr. Regulatory Affairs Specialist based in our Tokyo office. Osaka based work would be negotiable. In this role, the successful Sr. Regulatory Affairs Specialist will support regulatory activities across the full product lifecycle, driving efficient product registrations, maintaining compliance, supporting reimbursement initiatives, and acting as a key cross‑functional link to ensure regulatory readiness and continuous alignment with Japanese requirements.

Responsibilities include:

• Project Management & Information Sharing: Establish and maintain an effective NCC project management system to share regulatory affairs project information and accelerate product approval processes.
• Strategic Dossier Preparation: Seek the most reasonable approach to prepare submission dossiers and respond to PMDA inquiries while maintaining high compliance levels, including conducting risk analysis when required data is insufficient.
• PMDA Compliance & Timeliness: Prepare submission dossiers according to the latest PMDA requirements, analyze and share potential submission delays and associated risks with the team.
• Documentation & Record Management: Maintain comprehensive records of internal and external discussions with proper filing according to NCC RQR rules, ensuring accuracy as a key success factor.
• Regulatory Strategy Development: Demonstrate passion for technology and medical theory knowledge, and propose regulatory strategies to the team based on compliance requirements and flexibility within legal frameworks.
• Reimbursement & Clinical Expansion: Show flexibility and motivation to learn additional areas such as deeper reimbursement work or clinical matters as directed by NCC RQR Director for personal development goals.
• Quality Management System Knowledge: Possess sufficient QMS knowledge for regulatory affairs product submission work, QMS inspections, and reliability inspection work while supporting qualified supervisors.
• Continuous QMS Improvement: Demonstrate motivation to deepen QMS expertise to establish and improve the Quality Management System according to set procedures.
• Business License Management: Support license maintenance work including Foreign Manufacturer Registration (FMR), suggest renewal plans to NCC RQR Director with QA Sr. Specialist, and collaborate on license obtain/renewal projects.
• Stakeholder Relations & Regulatory Monitoring: Maintain and develop contacts with regional colleagues, business partners, industry associates, regulatory bodies, and medical societies while monitoring government legislation relating to PMDL (Pharmaceutical and Medical Device Law).

What makes this opportunity unique?

You will influence regulatory pathways for world‑leading implantable hearing technologies while expanding your expertise across reimbursement, clinical affairs, and advanced QMS work. This role offers rare exposure to both strategic and operational regulatory activities within a globally recognised organisation – all while contributing to meaningful patient outcomes.

About You

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:

• 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

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

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. 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