更新日 2025-03-14
掲載開始日 2025-03-14

RA Med Device @ Global Regulatory Consulting Full Remote

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 - その他メディカル/医薬/バイオ/素材/食品 - 薬事申請/特許技術関連
業種	医療機器メーカー
勤務地	アジア日本東京都
仕事内容	Take lead in medical device RA activities for client needs on various projects. Act as a key consultant for class I-IV products for local regulations. Description * Support the planning and implementation for product registration in class I-IV products for the company's medical device clients * Cover in various areas including in SaMD for end-to-end process of the product registration * Be the SME for the business when it comes to RA area * Ensure product registration translation work is correctly done * Provide any local/regional regulatory intelligence * Communicate with local health authorities (PMDA, MHLW, Prefecture bodies) Profile * University degree in scientific or related area * High fluency in English and Japanese (non-native level speakers will not be selected) * RA experience in the medical device industry * Track record of submitting products for class I-II (class III-IV preferred) to the PMDA * Experience in SaMD is preferred * Ability to communicate, negotiate, develop relationships with local health authorities Job Offer * Competitive salaries and benefits * Great work life balance * Fully remote option * Amazing career progression in RA Medical Device * Work with industry leaders who are solving various unmet medical needs * International working environment To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Saki Kanematsu at +81 3 6832 8904.
企業について（社風など）	* Global Regulatory/Quality consulting company specialising in the pharmaceutical, medical device, cosmetic areas * Rich project pipeline working with some of the top health care companies in the industry to support in regulatory and quality activities * Japan business grew exponentially within the past 5 years due to demand * Fully remote * International environment with extensive global collaboration
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 800万円〜 1500万円