ABOUT THIS ROLE
We are looking for a RA/QA Manager who can contribute to regulatory affairs and quality assurance tasks of medical device. The position will be also given an opportunity to assume a role of either quality assurance controller responsibility （Hinseki） or post marketing safety controller responsibility （Anseki） under The 2nd kind of MAH business license depending on the candidate’s experience and expertise. The position will play a significant role making sure that our Japan branch can expand its business scope to gain the 1st kind of MAH moving forward while as well as daily operation in full compliance with PMD Act. The position will report to the Senior RA/QA Manager of Japan.
In particular you can expect to:
－ Prepare product registration dossier for all classes of medical devices, including new registration and amendment applications, and take care of necessary communication with authorities as well as our global RA/QA counterpart through product approval/certification.
－ Control necessary product change as well as field safety information and reflect in necessary regulatory action in PMD Act. compliant manner.
－ Control FMR status and maintenance.
－ Control necessary business licenses and maintenance.
－ Control QMS, including relevant documents and activities.
－ Play a major role as Anseki or Hinseki, and make sure compliance of relevant activities, including document control and necessary employee trainings.
－ Collaborate with internal and external teams both inside and outside the country to effectively contribute to expected business output.
－ Provide support to senior staff and the management towards company priorities and business objectives.
As RA/QA Manager You will have the opportunity to:
－ Improve patient outcomes
－ Meaningfully impact the company’s short－term and long－term success
－ Work closely with executives across the organization
－ Grow your role as you see fit
－ Learn everything there to know about respiratory medical device manufacturing
－ Create an inspiring workplace
To be successful as RA/QA Manager, you will need:
－ Solid medical device regulatory application experience for more than three （5） years, favorably with foreign product introduction into Japan through English communication with the original designing and manufacturing sites.
－ Experience of Hinseki and/or Anski in the 2nd kind or higher MAH under PMD Act.
－ Good understanding of PMD Act. and QMS Ordinance.
－ Proactive, independent working attitude with ownership to the tasks assigned who can actively tackle with multi－tasks concurrently.
－ Team－player who can positively influence the other members at all levels with entrepreneurial can do attitude.
－ Proficiency of English in reading, writing, and speaking.
－ Bachelor of Science degree or higher in engineering or technical field preferred.