Regulatory Affairs Senior Specialist

CooperVision Japan (CVJ) is the largest operating business in the APAC region, based in Tokyo and is the second largest single country businesses in worldwide. Japan RA Senior Specialist (hereinafter referred as the RA Senior Specialist) shall be responsible for contributing and leading the Regulatory Affairs (RA) for the CooperVision Japan business. This individual is expected to be a strong assistant to the RA Manager and partner to Quality Assurance (QA) team, Vigilance team in Japan RAQA department and a proactive business partner to the Japan commercial team. The RA Senior Specialist shall follow the regulatory strategy for assigned corporate projects and obtains approvals for the Japan regulatory submissions. The RA Senior Specialist shall be responsible for all non-clinical studies required to demonstrate the safety and efficacy of contact lenses, which are classified as Class III high-risk medical devices in Japan. The focus of the role will be to exercise the leadership to ...