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Sr. Regulatory Affairs Specialist

extra holidays - extra parental leave
Remote: 
Full Remote
Contract: 
Full time
Experience: 
Senior (5-10 years)
Work from: 
Japan

Offer summary

Qualifications:

Bachelor's Degree required., 5+ years in medical device regulatory affairs and/or clinical affairs in Japan., Mastery of Japanese Pharmaceutical and Medical Device Law., Business level English proficiency..

Key responsabilities:

  • Manage regulatory product submissions for approval.
  • Ensure compliance with Japanese regulations and quality management systems.
Cochlear logo
Cochlear Large https://www.cochlear.com/
1001 - 5000 Employees
About Cochlear
Hear now. And always As the global leader in implantable hearing solutions, at Cochlear (ASX: COH) we are committed to our mission to help people hear and be heard. Our story started more than four decades ago when Professor Graeme Clark pioneered the world's first multi-channel cochlear implant and created an entirely new treatment for hearing loss. Since our formation in 1981, we continue Professor Clark’s work to help people with moderate to profound hearing loss experience a life full of hearing. We have provided more than 650,000 implantable devices. Each recipient helps form a global community of millions, through families, friends, colleagues, teachers and more. And they’re not just connected to their own community — each shares a link with each other and to Professor Clark’s childhood desire to help people hear. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We understand the privilege of connecting people to a life lived with hearing. And we listen, respond and move with the times – to continue to bring hearing within reach of all those who need it. That's how we live our mission every day. Our global workforce of more than 4,000 people shares a collective determination to give more people the opportunity to enjoy a life of hearing. Cochlear’s global headquarters are on the campus of Macquarie University in Sydney, Australia with regional headquarters in Asia Pacific, Europe and the Americas. Through our offices in over 180 countries we help people of all ages to hear. Social Media Terms of Use http://bit.ly/2qRMEvY
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Job description

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.

Job Overview & Purpose 

This role's primary mission is to accelerate products' approval to launch innovative products in the otolaryngology field in the Japanese Market by working as a project's member/ lead.

This primary mission includes to work based on enough knowledge about Japanese regulation including Regulatory affairs, Clinical 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 the RQR director. This includes 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 conduction clinical trials or PMS work, also for getting new reimbursement category.

Accountabilities 

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: 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 the new products which need to be submitted with the clinical trial data.
  • Seek the most reasonable regulatory strategy.
  • Prepare a dossier and response to regulatory body’s inquiries while highly compliance level.
  • Skills to read and comprehend regulatory requirements and to assess the impact on the NCC products.
  • Flexibility to adapt any changes in organization and having strong insights for keeping good compliance level to law and regulation.
  • Passion to know technology and medical theory.
  • Negotiation skills with Japanese authorities.

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: 

  • Ability to speak up when it is needed.
  • Comply existing SOPs and WI and contribute improvement those by communicating with team.
  • Keep seeking reasonable communication with team (NCC RQR, whole NCC, APAC RAQA and MA.)

                   

Minimum Key Incumbent Requirements 

Required Skills

  • Bachelor's Degree
  • 5 years or more of experience in medical device regulatory affairs and/or clinical affairs in Japan (Class III or IV) and its active worker.
  • 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.
  • General operation skill of MS Word, PowerPoint, Excel.
  • Flexible and reasonable communication skill.
  • Motivation to learn new things.
  • Native level Japanese proficiency.
  • Basic level of English proficiency.

 

Desired Skills

  • Expert knowledge of Japanese Pharmaceutical and Medical Device Law and the product registration process based upon clinical trial data including foreign clinical data.
  • Willingness to manage the long-term project and to resolve the complicated situation/subjects.
  • Bachelor's degree of science (pharmacy, engineering, microbiology, and so on)
  • Business level English 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.

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.

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Regulatory AffairsQuality ManagementMedical AffairsProject ManagementReimbursement RegulationsMedical Device DirectiveProject Management

Other Skills

  • Verbal Communication Skills
  • Microsoft Word
  • Microsoft Excel
  • Microsoft PowerPoint
  • Physical Flexibility
  • Self-Motivation
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