|募集背景||New position due to business expansion|
|仕事内容||Control safety and quality-related tasks with regard to GVP and GQP. Contact, negotiate with and report to HQ QA division related to safety information and product complaint. Contact, negotiate with and report to government authorities (PMDA, MHLW and Tokyo Metropolitan Government) for safety related issue. Receive audits by the authorities. Support maintaining business licenses for MAH, manufacturing, selling repairing of medical devices. Support regulatory compliance-related tasks (employee training etc)|
|応募資格||Knowledge required in laws (PAL etc) and regulations in Japan with regard to medical devices
Experience required in maintaining business licenses for medical devices
3+ year experience required in safety control of medical devices (class III or upper)
Must be flexible, patient, and have a strong will to develop themselves. Must be a good team worker. Must have well-developed interpersonal skills.
|年収・給与||7.0 to 12.0 million yen, based on qualifications and experience|
|休日休暇||Annual leave, weekends, national holidays.|