Leads enterprise sales from discovery calls and tailored demonstrations through new-account acquisition and existing-customer growth, while managing account plans and executive relationships.
About this role
A regulatory affairs role for the Daicel Injector, Daicel's medical device, based at the Tokyo head office. The company is relatively new to the medical device industry and advances projects step by step.
The specialist handles each country's regulations for the injector, obtains approvals and establishes and maintains the quality system they require: planning and executing regulatory strategy (mainly for overseas markets), preparing approval applications, monitoring relevant regulations in each country and maintaining the internal quality system. The role negotiates with the MHLW/PMDA, the FDA, overseas subsidiaries and overseas pharmaceutical companies.
Requirements: a master's or doctorate in a science, engineering, pharmacy or medical field; five or more years at a pharmaceutical company, medical device maker or certification body; overseas regulatory filing experience, especially with the FDA; five or more years of quality and regulatory practice; and willingness to accept a future transfer.
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