[Abiomed] Specialist, Regulatory Affairs

Responsibility
The RA Intermediate staff 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 and/or RA Senior Manager and/or RA Manager.

RA Intermediate staff is mainly responsible for the following RA duties:


* Support of project 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.).


* Preparation and submission of re-evaluation/re-examination application.


* 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.


* Support of preparation and submission of Health Reimbursement Application.


* Change management of SHONIN-Approval contents for approved device.


* 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

Required experience, skills, etc.


* 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, GVP etc.)


* Ability to communicate with relevant departments within the company and manufacturers.


* Intermediate English level (level to communicate with global RA by email)


* Basic PC skills (Excel, Word, PowerPoint, MS-Project, Photoshop, Illustrator, Adobe Acrobat etc.)

Desired experience, skills, etc.


* Experience in new SHONIN-Applications for Class-IV devices with no approval criteria (SHONIN-KIJUN)


* Knowledge of medical devices related to the treatment of heart disease


* Business English level (level to lead overseas telecoms)


* Knowledge of clinical operation such as clinical trials according to GCP and PMS according to GPSP


* Knowledge of statistical analysis