更新日 2024-05-15
掲載開始日 2024-05-15

RA Lead at New Market Entry Global Cosmetic Device Startup

人材紹介
マネージャーレベル

この求人の取扱い会社	マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.
企業名	会社名非公開
職種	メディカル/医薬/バイオ/素材/食品 - 薬事申請/特許技術関連メディカル/医薬/バイオ/素材/食品 - その他
業種	医療機器メーカー
勤務地	アジア日本
仕事内容	Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market. 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.
企業について（社風など）	* 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
英語能力	ビジネス会話 (TOEIC 735-860)
日本語能力	ネイティヴレベル
年収	日本・円 1000万円〜 1700万円