Job Description

Be part of one of the top leading global life science companies in the industry. Take lead in RAQA activities for the business as the "Sokatsu". Description * Act as the "sokatsu" for the business for MAH * Serve as the representative to ensure the business processes align with local regulatory requirements * Take lead in conducting external audits, ensuring compliance, and quality assurance agreements for company's manufacturers * Develop RA strategies to obtain regulatory approvals and maintaining existing products * Communicate, negotiate, and develop key relationships with health authorities * Utilize improvement activities, CAPA when necessary, to ensure high standards * Communicate with cross functioning departments to ensure product time lines are align with global strategy Profile * University degree in scientific or related field * High fluency in English and Japanese (non-native level speakers will not be selected) * Experience in RAQA for the medical device industry or related field * Track record of developing key relationships with local health authorities * Qualify as a Sokatsu locally Job Offer * Competitive salaries and benefits * Great work life balance * Hybrid working style * International environment * Amazing career progression in RAQA * Work with industry leaders who are solving various unmet scientific needs Page Group Japan is acting as an Employment Agency in relation to this vacancy.