募集情報

なぜ募集しているのか: Position: Senior Regulatory Affairs Manager

Overview
We are seeking an experienced Regulatory Affairs and Safety Management Manager to join our team. This role involves managing regulatory compliance and safety operations for medical devices, ensuring adherence to PMD Act and other relevant regulations.
どんな仕事か: Key Responsibilities
● Execute practical operations related to regulatory affairs and safety management
● Obtain Shonin approval and Ninsho certification for medical devices according to planned timelines
● Submit required regulatory notifications
● Manage QMS conformity inspections and surveillance inspections for product maintenance
● Handle procedures necessary for product marketing, including insurance coverage and compliance with related regulations
● Maintain regulatory documentation for approved/certified/notified products
● Oversee safety management operations
求められるスキルは: 必須 Required Qualifications

Education
● Bachelor's degree or equivalent

Experience
● Previous experience in regulatory affairs (RA)
● Safety management experience preferred

Language Skills
● English: Business level (reading, writing, and conversation)
● Must be able to communicate effectively with global team members in English

Core Competencies
● Strong communication skills for collaboration with internal departments, global manufacturers, and regulatory authorities
● Demonstrated problem-solving abilities
● Leadership capabilities in identifying challenges, planning, and execution
● Experience in cross-functional team coordination
雇用形態は: Full-Time/正社員
どんなポジション・役割か: Senior Regulatory Affairs Manager
どこで働くか: 埼玉県 / 千葉県 / 東京都 / 神奈川県
給与はどのくらい貰えるか: 800万円～ 1199万円

会社概要

社名: 非公開

事業内容・ 会社の特長: This global dental technology and equipment manufacturer is a leading provider of innovative solutions for dental professionals worldwide. With a rich history spanning over a century, the company offers a comprehensive range of products and services, including dental implants, CAD/CAM systems, imaging equipment, and consumables. Known for its commitment to research and development, the firm consistently introduces cutting-edge technologies that enhance patient care and streamline dental practices. Its products are used by dentists, dental specialists, and laboratories in over 120 countries, making it a dominant force in the dental industry.

取扱い紹介会社

ランスタッド株式会社　プロフェッショナル事業部

厚生労働大臣許可番号：13-ユ-010554
紹介事業許可年：2001年1月

登録場所: ランスタッド株式会社　プロフェッショナル事業部

〒102-8578 東京都千代田区紀尾井町4-1　ニューオータニガーデンコート21F

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Senior Regulatory Affairs Manager

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