職務内容

■職務内容
（雇入れ直後 / Immediately after hiring）

The Executive Director Regulatory Affairs is responsible for leading the development and execution of the global regulatory strategy for new product development and sustaining projects, the management of all regulatory activities in support of the business units, maintaining product registrations globally throughout product lifecycles and supports overall QARA objectives for Olympus.

The Executive Director Regulatory Affairs is responsible for developing and executing regulatory strategies to support corporate growth objectives for the business by providing guidance, strategy and management of regulatory activities needed for domestic and international expansion. The position requires strategic partnership with the cross functional business leaders for the strategy of introducing new devices to global markets. This role requires interaction with global regulatory agencies and notified bodies. This position is responsible for the management of the product regulatory affairs team, including prioritization of tasks, goals and objectives, performance metrics and professional development. Leads the development, implementation and oversees systems to support and ensure compliance with global regulations.


（変更の範囲 / Scope of change）
会社の定める業務
Business as defined by the company

■職務の魅力 

The number of products we deploy globally is at the top level in the industry, making this role responsible not only for product registration in Japan but also worldwide. As a result, it offers an opportunity to enhance a wide range of global expertise and regulatory affairs knowledge. It's a position where one can shape a very strong career trajectory as a playing manager.

■必須要件
Education: Bachelor’s degree in Engineering, Medical or Science (or similar) is required. Master’s degree preferred.
Experience:Experience in Regulatory Affairs within the medical device industry (minimum 15 years), with specific management experience, ideally in a matrix organization at a global company.
Experience similar to the Olympus product portfolio, applicable regulations and their application.
Experience designing, writing, submission of regulatory filings and correspondence, and/or approvals is required.
Experience managing the submission process for global regulatory approvals.
Direct experience interacting with and coordinating regulatory activities with global regulators.
Experience supporting end-to-end product lifecycle management for product portfolio in major markets, such as North America, EMEA, Japan, China.
Experience defining global regulatory strategy across a portfolio of products, in collaboration with key business functions.
Experience of working globally and understanding of global process flows.

Skills:Proven track record of successful regulatory approvals and maintenance of regulatory approvals in the medical device space.
Leadership and interpersonal skills to develop and manage good working relationships within Regulatory Affairs and with other internal departments (R&D, Manufacturing, Supply Chain, Quality etc).
Strong written and verbal communication skills in English and Japanese.
Strong IT skills: experience utilising a relevant regulatory system (desirable, e.g. RIM / PLM) and basic Office applications (essential), including MS Office (Word, Excel, PowerPoint, Outlook, Teams)

■雇用形態
正社員（試用期間3ヶ月：待遇の変更はなし）

■勤務時間 (マネージャークラス)
8：45～17：30 （休憩：昼45分）
　標準労働時間8時間　

※時短勤務制度あり
※テレワーク勤務あり・時間外労働あり

〈ご参考〉業務の状況等により変更となる可能性がございます

***************************************
■休暇・休日
・休日　　：土日祝、年末年始、GW、夏期休暇
・年間休日：129日（自社カレンダーに応ず）
・有給休暇：20日間の年次有給休暇を付与。
※入社初年度は入社月にて変動します（最大20日）
※時間単位での取得も可能です（一部条件有）

・育産休暇：取得実績あり（2022年度育児休暇取得率：女性94％※1、男性70.2％）
・特別休暇：結婚、出産、忌引き、転勤　など
・私傷病特別休暇
・治療との両立に伴う特別休暇（厚労省が支援を推奨する疾病に対して、特別休暇を付与）
・リフレッシュプラン
※対象年度の出産者の育児休業取得率は100％であるが、出産者の産後休暇が期間内に含まれるため94％となっています。

■想定年収・手当
1300万円～2000万円
※想定年収については、目安です。ご経験やスキルに応じて当社の処遇基準にて決定いたします
手当：交通費支給、次世代手当（管理職採用の場合対象外）、在宅勤務手当など

【保険】
社会保険完備（雇用保険、健康保険、厚生年金、介護保険、労災保険）

【福利厚生】※1
退職金制度：確定給付企業年金、確定拠出年金
育児サポート：企業内託児所、出産祝い金、ベビーシッター補助※2
その他：従業員持株会、財形貯蓄、カフェテリアプラン※3、社内食堂、社外シェアオフィス、健康診断※4、団体保険

※1）記載の福利厚生については各種規定、条件がございます
※2）内閣府企業主導型ベビーシッター利用支援事業
※3）自己啓発、健康増進、育児・介護支援など様々なメニューから選択して利用できます
※4）35歳以上の方は健康診断で内視鏡検査を受診する場合は全額補助が出ます

（雇入れ直後 / Immediately after hiring）
■グローバル本社（東京都）
働く場所は在宅・新宿サテライトオフィス・宇津木事業所・シェアオフィス（社外）なども可能です。
活用方法や頻度は部署と職種により異なります。詳細は面接時にご確認願います。

*新宿サテライトオフィス（東京都新宿区）
*雇用契約はグローバル本社にて締結します。

■受動喫煙対策　事業場内禁煙　

（変更の範囲 / Scope of change）
会社の定める場所( テレワークを行う場所を含む)
Workplace determined by the company(including the location where the telework will take place)