薬事
Regulatory Affairs Manager - Advanced Surgical
掲載期間:24/05/24~24/06/06求人No:RSP-LS-BXRAM2
再掲載薬事

Regulatory Affairs Manager - Advanced Surgical

外資系企業 上場企業 大手企業 英語力が必要 土日祝休み

募集要項

募集背景
Overview:
Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more countries. Typically, will supervise or mentor more junior employees.
仕事内容
Key Responsibilities:

● Develop and execute regulatory strategies/ plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
● Lead the RA function on assigned cross-functional project teams
● Monitor applicable regulatory requirements; assure compliance with the company and external standards
● Establish appropriate communication within RA and other functions at the project level and to senior management
● Perform gap analysis and propose solutions
● Develop and document sound regulatory decisions and justifications
● Ensure project teams, business objectives and deliverables, and regulatory strategy are aligned
● May provide direct supervision of individuals
● May review promotional material or SOP’s for compliance with local and global regulations
応募資格
必須
Qualifications:
● Sound basis of Regulatory knowledge in general
● Experience in creating and managing Class IV device submissions
● Sound basis of Regulatory knowledge in country of interest
● Scientific Knowledge – ability to understand Advanced Surgery products and uses
● Ability to manage complex projects and timelines in a matrix team environment
● Strong oral and written communication and presentation skills – ability to work closely and effectively with the Global RA and project teams.
● Demonstrated interpersonal skills including strong negotiation skills
● Ability to independently identify compliance risks and escalate when necessary
● Ability to lead and coach others – internal and external partners

Education & Experience:
● Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 10 years regulatory experience in RA or related field, including managing people or projects.
● Higher degree/PhD will be an advantage. Ability to communicate effectively using Japanese and English.
雇用形態
Full-Time/正社員
ポジション・役割
Regulatory Affairs Manager - Advanced Surgical
勤務地
Saitama Prefecture / Chiba Prefecture / Tokyo / Kanagawa Prefecture
年収・給与
11 million yen ~ 12.99 million yen

会社概要

社名
非公開
事業内容・会社の特長
A global healthcare organization renowned for its commitment to advancing medical solutions and improving patient outcomes. With a rich history dating back several decades, this company operates on a global scale, offering a diverse portfolio of products and therapies across various healthcare domains.

Primarily focusing on lifesaving and sustaining solutions, this company specializes in developing and manufacturing a wide range of medical products. These include intravenous (IV) solutions, infusion systems, and other critical medical devices that play a vital role in patient care and treatment. The organization is dedicated to addressing the evolving needs of healthcare professionals and patients, with a focus on innovation and cutting-edge technology.

With a global presence, this medical company collaborates with healthcare providers, institutions, and professionals to deliver high-quality, reliable healthcare solutions. Its commitment to diversity, equity, and inclusion is evident in its workforce and corporate culture. The company values the diverse perspectives of its employees, fostering a collaborative and inclusive environment.

この求人の取扱い紹介会社ご相談や条件交渉などのサポートを行います。 取扱い紹介会社の詳細へ

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
設立
1980年8月4日
資本金
1億
代表者名
代表取締役社長兼COO 猿谷 哲
従業員数
法人全体:---

人紹部門:---
事業内容
■人材紹介
■人材派遣
■紹介予定派遣
■再就職支援
■人材コンサルティング
厚生労働大臣許可番号
13-ユ-010554
紹介事業許可年
2001年1月
紹介事業事業所
東京
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
ホームページ
https://www.randstad.co.jp/professionals/
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A.
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また、より良い待遇条件で転職が決まるように条件面での交渉をしてもらえます。
Regulatory Affairs Manager - Advanced Surgicalの転職・求人情報 24349232。プロのコンサルタントがサポートする日本最大級のキャリア転職情報サイト。年収800万円以上の高年収、管理職、スペシャリストの求人、非公開求人スカウトも多数。