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Senior Clinical Affairs / Regulatory Affairs Specialist

Apply now Job no: 610730
Work type: Permanent
Location: Tokyo
Categories: Asia Pacific, Individual Contributor, Quality & Regulatory

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. 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 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. Our implantable hearing device portfolio includes cochlear implant systems (Nucleus®) and bone conduction implant systems (Baha®)

 

The Opportunity

We are seeking an Senior Clinical Affairs / Regulatory Affairs Specialist, reporting to the Director, RA/QA based in our Tokyo office. In this role, the successful Sr. CA/RA Specialist will have the opportunity to accelerate clinical trials and products' approval for Japanese Market by working as project’s member. Depends on the person’s skill, experience and motivation, the position might lead the project. This primary mission includes to work based on enough knowledge about Japanese regulation including Clinical affairs, Regulatory affairs and Quality management area that should be known by CA and RA person for product submission.

This role also should contribute on increasing compliance level according to Japanese Pharmaceutical and Medical device law by helping qualified supervisors and RQR director. This is including expectation to maintain business licenses that NCC has.

This role might be involved reimbursement project. This role is supposed to have motivation to learn about reimbursement system not only as a CA and RA specialist but also as project member of reimbursement specific matters.

This role will might work with external experts for Pre-approval clinical trial for regulatory purpose or PMS work when new product submission and QMS relevant work will be slightly at that period.

Key Responsibilities

Accountability 1:   General

  • 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

 

Accountability 2:   Clinical trial and Regulatory product Shonin work

·        Contribute establish and maintain effective project management system of NCC to share RA project relevant information to accelerate product approval especially for new product which will require data from clinical trials attached to regulatory application.

·        Compile necessary material for submission dossier including clinical trial notification and study protocol, and consultation with the regulatory bodies for new product must be needed. This includes collaboration work with CRO (Contract Research Organization) and other related organization (clinical trial sites, outside lab conducting some additional tests, etc.).  

·        Coordinate all clinical trial work including other IRB procedure, etc. in cooperation with CRO, if domestic clinical trial data is required.

·        Seek the most reasonable way to prepare dossier and response to regulatory body’s inquiries while highly compliance level. When the dossier cannot have 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 based on the latest regulatory body’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.

·      This position will be involved in PMS. Positive and aggressive attitude for PMS is also important factor.

·      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.

·      Clinical and regulatory strategy must be suggested to team based on the listed items here.

Accountability 3:   Quality Management System

·        Enough knowledge about QMS for RA product submission work and QMS inspection and reliability inspection work is minimally required.

·        Supporting 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:   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 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 to direction by RQR director or project managers/leaders.
  • Comply existing SOPs and WI and contribute improvement those by communicating with team.
  • Keep seeking reasonable communication with team (NCC RQR, whole NCC, APAC RQR and other Cochlear people)

 

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:

Minimum

  • Bachelor’s Degree
  • 5 years or more of experience in medical device clinical affairs and regulatory affairs in Japan (class III or IV) and its active worker
  • Expert knowledge of Japanese Pharmaceutical and Medical Device Law and the product registration process based upon clinical trial data including foreign clinical data
  • 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 CA/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.
  • Over sea 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 English proficiency

In turn, you will have the unique opportunity to work in a multinational, Australian-owned organization engaged in delivering life changing technology.

 

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 Organisation – 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.

 

 

 

 

 

 

 

 

 

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