RA/QA manager / バイエアメディカル合同会社
We are looking for RA/QA manager who can contribute to regulatory affairs and quality assurance takes 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 2nd of MAH business license depending on the candidate’s experience and expertise.the position will play a significant role making sure that our Medical Japan to expand its business scope to gain 1st kind of MAH moving forward while as well as daily operation in full compliance with PMDAct. The position will report to Senior RA/QA Manager of Japan.
In particular you can expect to:
・Prepare product registration dossier for all classes of medical device including new registration and amendment applications and take care of necessary communication with authorities as well as our medical 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 PMDA 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 documents control and necessary employee trainings.
・collaborate with internal and expected business output.
・Provide support to senior staff and the management towards company priorities and business objectives.
You will have the opportunity to:
・lmprove 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
|求める経験||To be successful you will need:
・Solid medical device regulatory application experience for more than 5years favorably with foreign product introduction into Japan through English communication with the original designing and manufacturing sites.
・Experience of Hinseki and/or Anseki in 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 mult task 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.
One of our unique strengths is the diversity of our community.We want to treat each associate fairly and provide equal employment opportunities regardless of a person’s race color religion gender or gender identity sexual orientation age marital status national origin veteran or disability status or any other characteristic.
|年収||750万円 - 1000万円|