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Regulatory Affairs Manager － Medical Device （Japan）
年収：800万 ～ 1000万
採用企業案件
役員面接
グローバルレギュラトリーパートナーズ合同会社
-
- 会社規模非公開
- 医薬品メーカー
| 部署・役職名 | Regulatory Affairs Manager － Medical Device （Japan） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Job Offer Summary: ? Title: Medical Device Specialist ? Department: Regulatory Affairs ? Working Style: Hybrid ? Position: Part-Time Contractor ? Area: Toronomon, Tokyo ? Company Type: Foreign Multinational ? Age Limit: No Age limit for applicants Summary: Regulatory Affairs Manager position as expert of registration for Medical Devices with PMDA. Responsibilities ? Monitor and guide the organization to improve in compliance with the latest J-PMD Law and related ordinances / regulations required for Medical Device MAH （Manufacturing Authorization Holder）. ? Participate in and facilitate cross functional team for new product introduction to provide expertise in regulatory strategies. ? Compile and register technical files for Medical Devices (Class I -IV) ? Research assesses and/or consults to identify on regulatory requirements to register new or changed products. ? Assess and/or consult to identify QMS requirements to register new or changed products. ? Develop strategies and plans to register and/or launch assigned product and execute by ? coordinating internal and external stakeholders to complete its registration. ? Administer communication with the regulators to support their review of our regulatory applications. ? Monitor the progress of the preparation and review status by the local team outsource and regulator to update the international team and management at regular basis. ? Lead and consult preparation execution of reimbursements application. ? Monitor and assess regulatory impacts of new and revised regulations guidance and standard. ? Review and approve new and revision of design manufacturing input from the manufacturers suppliers to ensure the compliance along with Japanese regulatory requirements. ? Draft revise review consult and/or approve labelling to ensure the compliance to corporates requirement Japanese regulations. ? Review and/or approve labelling to ensure they are documented and produced in compliance to domestic internal requirements on QMS ? Register and maintain QMS Accreditation of Medical Device. ? Register and maintain MAH manufacturing Repairing Distribution and other licenses necessary for local distributor of the products. ? Support QA team by providing regulatory insights to support creation and update of use/user’s manual PMS reporting and field actions. ? Participate in maintenance and improvement of regulatory and development processes to support compliances. EXPERIENCE ? 7 years or more of experience in regulatory affairs for medical devices. ? 3 yrs. or more of experiences as one or more of representative of Medical Device MAH （Sokatsu Hinseki or Anseki Preferred. SKILLS ? Experience with communication with PMDA or notified body reviewers. ? Good communication skills in English （written and oral） ? Excellent Communication Skills- inter department communication necessary. ? Sufficient PC skills to administer regulatory datasets and their revisions ? Excellent team player Preferred. ? Knowledge and experiences on Medical Devices ? Experience on pre submission consultation with PMDA ? Experience to have participated in registration project with international stakeholders. ? Facilitator ? Good analytical and problem-solving skill ? Self-motivator and self-learner |
| 労働条件 |
【勤務地】 Job Location : Japan , Tokyo 【雇用形態】 Job Type: Permanent Full-time (remote) |
| 応募資格 |
【歓迎（WANT）】 【REQUIRED QUALIFICATIONS】・3 years or more of experience in regulatory affairs for medical devices above class 4 ・Experience with communication with PMDA or notified body reviewers. ・Good communication skills in English （written and oral） ・Sufficient PC skills to administer regulatory datasets and their revisions ・Excellent team player Preferred ・Knowledge and experiences on Surgical Devices ・Experience on pre submission consultation with PMDA ・Experience to have participated in registration project with international stakeholders. ・Experience or knowledge on QMS Accreditation and ISO 13485 requirements ・3 yrs. or more of experiences as one or more of representative of Medical Device MAH （Sokatsu Hinseki or Anseki） ・Facilitator ・Good analytical and problem-solving skill ・Self-motivator and self-learner 【GENERAL REQUIREMENTS】 ・Minimum Experience Level: 3-year ・Career Level: Mid-Career ・Minimum English Level: Daily Conversation ・Minimum Japanese Level: Native ・Visa Status: Permission to work in Japan required |
| アピールポイント | 管理職・マネージャー |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/03/27 |
| 求人番号 | 3217178 |
採用企業情報
- グローバルレギュラトリーパートナーズ合同会社
-
- 会社規模非公開
- 医薬品メーカー
-
会社概要
【設立年月日】2016年10月25日
【本社所在地】東京都港区虎ノ門5丁目13-1
【事業内容】
外資系医療機器および医薬品メーカー向け製造販売業務、コンサルティング業務
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です