[Abiomed] Specialist, Regulatory Affairs
Synthes GmbH
Date de publication :
07 octobre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Zuchwil
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