※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Salary] 9〜10 million JPY ※Experiences and skills will be considered
This position is responsible for managing all facets of regulatory and market access support to Spine businesses. In addition to managing projects and leading a RA team of market access professionals, this position involves interaction with government authorities and hands on work in dealing with product submissions. In order to achieve Company objectives, a comprehensive understanding of products and their use, as well as an understanding of regulations and their application is required.
Overall management of Spine product segments projects, including working closely with regional RA & Global manufacturing sites to drive reduction of registration cycle time through Speed to Market initiatives.
Define and implement Japan regulatory & reimbursement strategies and plans
Manage and track Speed to Market performance for Japan
Update registration cycle time metrics on a quarterly basis
Update comprehensive commentary report on a yearly basis
Create application documents (new/supplement/ninsho) and follow process through to approval
Partner with CRO for regulatory clinical studies
Partner with QA/QC to create and review labeling
Partner with Commercial to create C1 Reimbursement application
Provide guidance and consultation for regulations
Bachelor's Degree in Life Sciences, technical (engineering) or related field; advanced degree in engineering advantageous.
10 years experience in medical industry, with a minimum of 5 years experience in a Regulatory Affairs role.
3 - 5 years people management experience.
Experience in electrical equipment and combination products regulations is strongly preferred.
A combination of education and experience may be considered.
Superior people management and leadership skills
Highly motivated and strong project management skills
Strong strategic mindset and hands on approach
Excellent communication and interpersonal skills
Responsible, professional, detail oriented and patient
Proficient in reading, writing and speaking English (TOEIC 600+)
Occasional domestic and international business trips
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider