[Abiomed] Manager, Regulatory Affairs W
Description
The RA manager will comply with the Pharmaceutical Affairs Law and related enforcement regulations, enforcement ordinances, ministerial ordinances, notifications, etc., carry out RA duties in cooperate with the Quality Assurance Department and the Clinical Research Department, and report to the RA Director (Regulatory Strategy Planning).
RA manager is mainly responsible for the following RA duties:
- Budgeting and planning for RA works represented by SHONIN-Submission, TAIMEN-JOGEN with PMDA etc.
- TAIMEN-JOGEN with PMDA regarding unclear points about RA.
- Preparation and submission of SHONIN/NINSHO Application or Notification (new, partial change, notification, minor change notification etc.).
- Responding to inquiries after submission for SHONIN, NINSHO, Re-evaluation and Re-examination.
- Respond to reliability inspection for clinical and/or non-clinical evidence after SHONIN/NINSHO submission.
- Preparation and submission of Health Reimbursement Application.
- Change management of SHONIN-Approval contents for approved device.
- Preparation and submission of re-evaluation/re-examination application.
- Education and training related to RA.
- Participation in industry groups, etc. and internal activities in accordance with requests from industry groups.
- Support work for Quality Assurance Department or Clinical Research Department
Qualifications
- Work experience in a medical device company (5 years or more)
- 5 years of RA experience
- Familiar knowledge of the Pharmaceutical Affairs Law and related enforcement regulations, enforcement orders, ministerial ordinances and notifications (including QMS, ISO13485, GCP, GPSP, etc.)
- Ability to communicate with relevant departments within the company and manufacturers.
- Business English level (level to lead overseas telecoms)
- Basic PC skills (Excel, Word, PowerPoint, PDF, etc.)
Desired experience, Skills, etc.
- Knowledge of medical devices related to the treatment of heart disease
- Knowledge of clinical operations such as clinical trials according to GCP and PMS according to GPSP
- Knowledge of statistical analysis
- People management experience
Primary Location Asia Pacific-Japan-Tokyo-Tokyo Nihonbashi
Organization Abiomed Japan K.K. Legal Entity
Job Function Regulatory Affairs
Req ID: W
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