Senior Director Japan Lead, QARA Compliance

品質保証・薬事

職務内容／Job duties	【PURPOSE/SUMMARY】・This role will be responsible for overseeing regulatory compliance across the operating sites and businesses in Japan. The Senior Director Japan Lead, QARA Compliance will work directly with local management to ensure that medical device regulatory compliance responsibilities are consistently maintained and that the organization demonstrates the necessary actions to support quality system continuous improvement regulatory compliance. The Senior Director Japan Lead, QARA will work cross-functionally with Business, Operations, R&D and local Quality and Regulatory Affairs to align and prioritize compliance response actions as necessary. The role is an extension of the Corporate QARA Compliance organization and is responsible to act on behalf of the Compliance organization as follows:Seeing that all compliance program policies, procedures, training, auditing and monitoring are in place for the subsidiary businesses and for investigating or supporting investigations of any allegations of non-compliance related to these businesses. ・Ongoing implementation and enhancements to international compliance initiatives. ・Provide compliance status reports to business partners and the Corporate Quality & Regulatory Affairs Compliance Leadership Team The Senior Director Japan Lead, QARA will routinely report on the status of regulatory compliance across the Japan operations sites and escalate events that are considered to be compliance risks and require prompt actions. 【PRIMARY DUTIES AND RESPONSIBILITIES】・Managing and enhancing the interface of the global compliance auditing and monitoring plans with the Japan operating sites and leadership. ・Overseeing the performance of subsidiary and third-party compliance auditing and monitoring plans, within and between the Japan operations sites and effectively document and report findings. ・Work closely with regional and local Quality & Regulatory Affairs and management colleagues, to effectively advise on a wide range of compliance issues as well as proactively identify areas for business enhancements and of non-compliance with legal requirements, regulatory guidelines, and/or written standards. ・Assist in the development and presentation of periodic reports to the Chief Quality Officer, Global Executive Committee and BOD Quality Compliance on status of annual auditing and monitoring plan, summary of findings, and the implementation of remedial measures. ・Develop and propose value-adding practical recommendations and compliance remediation process in response to the observations identified in the auditing and monitoring plans. ・Educate internal stakeholders across the organization regarding the quality function and their role in ensuring quality standards and regulatory compliance are sustained ・Contribute to regional and global compliance assurance methodology projects and continuous improvement initiatives ・Where required, serve as a point of contact with internal and external audits and regulators. ・Strong knowledge of the good manufacturing practices (GMP) / Good Distribution Practices for Medical Device (GDPMD) regulations ・Support critical external inspections (e.g., FDA, NMPA). Stay updated on emerging regulations and industry trends affecting device quality and regulatory affairs. ・Serve as a key member of the device quality & regulatory leadership team, contributing to the strategic direction of the company’s product pipeline and regulatory strategy. ・Liaise with external partners, suppliers, and regulatory bodies to support product launches and lifecycle management. ・Seeing that all compliance program policies, procedures, training, auditing and monitoring are in place for the subsidiary businesses and for investigating or supporting investigations of any allegations of non-compliance related to these businesses. ・Ongoing implementation and enhancements to international compliance initiatives. ・Liase with regional and global regulatory agencies and medical device industry representatives in local forums, conferences and educational workshops. ・Provide compliance status reports to business partners and the Corporate Quality & Regulatory Affairs Compliance Leadership Team ・Develop and implement annual and long-term strategic compliance plans in collaboration with company Compliance Operations that reflect the seven elements of an effective compliance program for the subsidiary businesses and provide support to the compliance professionals that support these businesses. （変更の範囲 / Scope of change）会社の定める業務 Business as defined by the company 【採用人数】 1名
応募資格／Qualifications	【必須要件】 ◆Education◆ Bachelor’s degree in Science or Engineering discipline. ◆Experience◆ ・Minimum of 15 years related experience in Quality and Regulatory Affairs management in Medical Device company. ・Strong knowledge and experience in FDA medical device quality system requirements including participation in and management of FDA inspections. ・Knowledge and experience in implementing and sustaining ISO 13485 medical device quality system standard, EU MDR, Japan PMDA, China NMPA. ◆Skills◆ ・Successful interactions with global Quality teams and local authorities. ・Demonstrated experience in cross-functional leadership skills, ・Good knowledge of supervisory/ management experience, including hiring. training, coaching and performance management activities. ・Advanced written communication skills; ability to communicate clearly and concisely with business and technical stakeholders. ・Ability to work collaboratively and effectively across matrix organizations in a fast-paced organization. ・Ability to lead, develop, and effectively manage employees operating in Japan. ・Strong interpersonal relationship building and employee coaching/ development skills ・Advanced written communication skills; ability to communicate clearly and concisely with business and technical stakeholders. 【選考フロー】 ※適性検査の有無、面接回数は求人（職種）により異なりますので、予めご了承ください ※本ポジションは選考にあたり英文レジュメのご提出が必須となります。日本語の履歴書・職務経歴書と併せて、ご提出をお願いいたします。書類選考→面接：3回～4回（ポジションに応じて増える可能性があります） ※面接は基本webでの実施です
待遇／Salary & Benefits	【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】 8：45～17：30 （休憩：昼45分）　標準労働時間8時間 ※フレックスタイム制度あり（管理職採用の場合対象外）　コアタイム11：15～13：30 ※時短勤務制度あり ※テレワーク勤務あり【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】 1200万～2000万 ※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
勤務地／Location	（雇入れ直後 / Immediately after hiring） ■グローバル本社（東京都八王子市石川町2951）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（東京都新宿区西新宿2-3-1 新宿モノリス）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)