RA Lead at New Market Entry Global Cosmetic Device Startup

Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market.
Client Details
* Global cosmetic medical device company
* Specializing laser treatment for skin treatment
* year on year growth globally
* Prides themselves on innovation and cutting-edge products for various unmet medical needs
* Globalized culture collaborating with patients and other healthcare professionals worldwide
Description
* Lead in regulatory submissions for company products to obtain product approval
* Develop effective regulatory strategies and collaborate global stakeholders to align business growth
* Communicate, negotiate, develop key relationships with health authorities (PMDA, MHLW, etc.)
* Be the key person to share necessary regulations/compliance requirements in Japan
* Manage any regulatory changes, procedures, if required
* Participate in internal and external audits
Profile
* University degree in scientific or related field
* Fluency in English and Japanese (Non-native level speakers will not be selected)
* Experience in successful submissions for approval for medical device products in Japan even class I-II can be considered
* Ability to work independently with collaboration with global stakeholders
* Develop key relationships with local health authorities (ex. PMDA, MHLW, prefectural bodies)
Job Offer
* Competitive salaries and benefits
* Fully remote working style
* Be the first person in Japan to launch the business
* Work with industry leaders who are solving unmet medical needs
Page Group Japan is acting as an Employment Agency in relation to this vacancy.