Global medical devices in-vitro diagnostics manufacturer.

Regulatory Affairs Senior Director at IVD manufacturer || 薬事シニアディレクター (IVDメーカー)

Directs and leads all Regulatory Affairs activities for Japan. The individual will develop and implement regulatory strategies that insure the approval of well-designed, high-quality medical devices/in vitro diagnostic tests. Provides guidance and counsel to both global and local senior management, R&D project teams on regulatory matters and ensures the timely preparation of organized and scientifically valid regulatory submissions. Provides regulatory guidance for analytical, and clinical study designs; protocol development and all PMDA/MHLW pre-market and post-market submissions and quality system establishment.

・Extensive knowledge of local and preferably global medical device regulations and standards for IVD (In vitro diagnostic) products
・Understands MHLW/PMDA intent rather than just requirements
・Written skills to prepare documents including but not limited to strategy documents, submissions to regulatory agencies
・Entrepreneurial mind set
・Open communication style, able to speak his/her mind
・Advanced degree (e.g. M.Sc., Ph.D., M.D., Pharm.D.) in the Biological, Medical, Law, Chemical or Engineering field.
・Regulatory Affairs Certification preferred
・Minimum of 10 years of medical device / pharmaceutical / biologics development experience in regulatory environments, including leadership and/or senior consulting　experience.
・Minimum of 5 years managing RA department.
・Hands-on experience with regulatory submissions.
・Solid track record of successful interactions with MHLW/PMDA.
・Thorough understanding of the MHLW/PMDA, CFR, FDA/ICH guidelines and cGMP’s, as they pertain to medical devices, current industry trends as related to diagnostics, pharmaceutical and biological products.