דרושים Regulatory Affairs Manager ב-Philips ב-Japan, Chiyoda

品質保証部マネジャ/ Quality Assurance Manager

【背景】/【Back Ground】

【サマリー】/【Job Summary】

Responsible for all aspects of quality assurance and quality management system (QMS) development, operation, and maintenance for medical devices, in collaboration with global HQ/ legal manufacturer and internal departments, based on medical devices sales, rental, and repair services in accordance with applicable laws, regulations, standards and company requirements.

【業務内容】/【Your roles and Key Areas of Responsibilities】

• 適用規制やISOの遵守事項を把握し、社内QMSへの適合を企画推進する
• 海外法人のQMSスタンダードへの適合プロジェクトを推進する
• 品質目標の管理を確実なものにし、QMSの適合性を評価し、マネジメントに報告する
• 文書管理・教育訓練管理をQMS全体で確実なものにする
• 業許可変更管理を確実に実行する
• 社内外との品質取決め書を維持管理する
• 内部及び外部品質監査への対応する
• 社内の品質マネジメントシステムへの移行及び展開に係る各種業務を行う
• 品質の確保、苦情処置、不適合品の管理、是正予防および改善、回収処理、製造販売業者への不具合等報告および連携を行う　等

• Understand requirements by applicable regulations and ISO standards, and plan and promote compliance with the internal QMS.
• Execute projects to ensure compliance with QMS standards by global HQ/legal manufacture.
• Ensure quality objectives, evaluate QMS compliance, and report to management/ stakeholders.
• Ensure document/record controls and training management throughout the QMS.
• Ensure the proper execution of regulatory licenses change management.
• Maintain and manage quality agreements with internal and external parties.
• Respond to internal and external quality audits.
• Engage projects/tasks related to the transition and implementation of the internal quality management system.
• Ensure quality assurance, complaint handling, manage nonconforming products, implement corrective and preventive actions, recalls, reporting defects to MAH (e.g. Philips Japan), and coordinate with them, etc.

【要件（必須）】/【Requirements (Mandatory)】

• 医療機器業界において5年以上の経験を有し、そのうち最低3年は品質部門での経験を有する方。
• 医薬品医療機器等法、ISO13485及び他関連する規制要件の知識を有する方。
• 医療機器の品質マネジメントシステムのプロセスの構築と運用の経験を有する方。
• 語学力： 日本語及び英語力（海外法人とコミュニケーション可能なビジネスレベル）

• > 5 years of experience in the medical devices industry, of which with a minimum of 3 years within quality field such as QA/QMS.
• Knowledge of the PMD Act, ISO 13485, and other applicable regulatory requirements.
• Experience in establishing and operating quality management systems for medical devices
• Language: Japanese (Native level), English (Business Level)

【尚可】/【Requirements (Preferred)】

• AED/除細動器やその他の救急医療製品について十分な理解を示している方。
• 医療機器ライセンスの取得とその後の維持管理の経験を有する方。
• 事業拡大の進捗に応じて、品質部門の最適な組織体制を設計管理できる方。

• A thorough understanding of AEDs, defibrillators and other emergency care medical devices
• Experience in obtaining medical devices licenses for a newly established legal entity and maintaining it thereafter.
• Ability to design and manage the optimal organizational structure for the quality department in accordance with business expansion progress.

Market Procurement Manager

Job Role:

• You will have the opportunity to contribute to the Philips Offering for Medical Equipment, Service and Software to our customers in Japan. Supporting the sales and services organization while making the connection with the Business Units through Business Partners, you will ensure Compliance/Quality, Cost and Delivery for all 3rd Parties Products & Services (such as Image Chain, OEM Systems, Medical Devices, Service Rental…), in addition to the Philips’ own systems and devices in the deal package. This may include stand-alone hospital offer, regional multi-modality deals up, to large government projects at the country level.

Key Responsibilities:

• You are responsible for 40 M€ spend through about 40 suppliers.
• Single Contributor Position locally. Focus given on diversity in large.
• Representing and positioning Procurement, interacting with key internal stakeholders, including Business Marketing Leader, Supplier Quality, Supply Chain & Legal team.
• Further defining the Procurement value proposal, balancing a project base approach into a Category and Project angle - promoting our standard catalog items.
• Ensuring 100% compliance through our own team according to local regulation, our Quality Management System, new Master Agreement, Cybersecurity directives and internal Policy.
• As part of continuous improvement, to propose and/or implement key process changes within your team and facilitate with other stakeholders.
• Implementing, with the Market Procurement Leader, the procurement strategy, country specific.
• Boosting and maintaining the short and mid-term productivity funnel, focusing on P&L impact, leveraging Year Over Year productivity (e.g. supplier consolidation, redesign to cost approach, strong negotiations practices….).
• Maximizing assurance of supply to safeguard our revenue and customer satisfaction.
• Managing the supply base (segmentation, consolidation, risk management, performance monitoring).
• You are a part of the Integrated Supply Chain and Procurement organization. As such, you will report into the Market Procurement Leader – International Markets.

You are part of The Integrated Supply Chain and Procurement organization, reporting to the Market Procurement Leader – International Markets.

You're the right fit if:

• A Bachelor’s degree, complemented with a last degree in Business, Supply chain or Procurement is preferred.
• A minimum of 5 years’ experience in Direct Procurement / Supply Chain/ Project Management within a Global matrix Medtech environment is needed as well.
• General know-how in Medical Devices or 3rd Parties ~ Brand-Labelling equipment, associated service (Installation, repair, ….) ; and overall regulation are real plus.
• Experience in sales/marketing/ project management is a plus. A first successful people management experience is appreciated as well – preference given in a multi-cultural context.
• Training / Certification in Lean or changing the acceleration process would help.
• Business acumen and constant inclusiveness, working hand with the Business Units, Market and Q&R management representatives.
• She/he will combine a “customer first” view together with no compromise on compliance.
• She/he will have influencing skills to challenge in a constructive way, legacy and status quo.
• Japan and English (750~) must have.

【休暇】初年度有給休暇　最大20日間（2年度～5年度 20日／6年度以降 25日 付与）、CareLeave（年間10日間）、Sick Leave（年間最大30日間）ほか

【研修制度】 各種オンライン研修、入社後のサポート研修あり

【その他】PhiliFlexポイント：72,000 ポイント（1ポイント＝1円）

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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You will focus on Product Industrialization. Driving operational finesse, efficiency, availability, quality and lead-time and developing long-term plans to support business expectations. Other key areas are building Design for Manufacturing (DFM)/ Design for Supply Chain (DfSCM) processes, technology roadmaps, core/non-core assessments, make-or-buy decisions, CAPEX investments, customization strategies, first-time-right NPI and establishing a culture of continuous improvement.
Your role:

• Project Management of all work to meet Schedule, Cost, and Quality Requirements
• Balancing multiple interdependencies and business risks related to product introduction activities
• Ensuring optimum process capability, alignment to quality standards, and DfMAT (design for manufacturability, assembly and test) best practices are leveraged
• Leading and cooperating with an Operations project team including engineering, procurement, quality, logistics, catalog management and manufacturing
• Representing Operations in the integral project team and acting as Single Point of Contact between Operations and the cross- functional project team
• Identifying and Drivingmanufacturing/engineering/valuechain improvements during product development projects & transfer projects and drive product improvements with regard to variety, cost, quality and failure rate, implementing DfMAT principles
• Identifying the impact of new products on the current supply chain architecture and manufacturing concepts in order to develop the required architecture and solutions, initiate the deployment and define guidelines and complete implementation
• Being responsible for the implementation in the supply chain of project related Engineering Changes
• Cooperate with partners to define concepts of new products with efficient landed costs
• Driving make/buy decisions and be involved in supplier selection process
• Driving operational excellence of project execution to achieve first time right predictable project execution

You're the right fit if:

• Bachelor/Master degree in a technical field(Mechanics/Electronics,Industrial Engineering, Supply Chain etc.) and preferably demonstrated ability in the relevant domain.
• Conceptual thinking capabilities (Translate Global Architecture to requirements and Design and resolve production impact)
• Hands-on can-do mentality.
• Preferably understanding of process FMEA’s, design reviews, process validation and knowledge of production process design and relevant knowhow of Logistics/Supply Chain.
• Strong communication skills, embrace good documentation practices and project- and stakeholder managements skills.
• Ability to lead a team of specialists through the product introduction cycle
• Proficiency in English language
• Preferably experienced with problem solving techniques
• Promoter of inclusion & diversity

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
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• Establishes an annual planning horizon, aligning team objectives with strategic goals and ensuring proactive preparation for upcoming initiatives, fostering strategic alignment and proactive readiness.
• Executes the organization’s strategy effectively, establishing clear success criteria and accountability levels for team members, ensuring alignment with overall goals.
• Defines, measures, and achieves key operational metrics such as performance, incidents, capacity, and availability, ensuring operational efficiency and effectiveness.
• Cultivates an environment fostering performance and quality in customer satisfaction, technical expertise, and process improvement, promoting continuous learning and development.
• Implements quality review and continuous improvement practices, addressing trends and enhancing work instructions and customer service outcomes, ensuring ongoing enhancement of service delivery standards.
• Utilizes Information Technology Infrastructure Library (ITIL) or equivalent techniques to drive operational efficiency at the business and departmental levels, optimizing processes and workflows for maximum effectiveness.
• Collaborates with internal and external stakeholders to stay abreast of technological developments, identifying trends and opportunities for innovation, fostering a culture of continuous learning and adaptation.
• Ensures the team is adequately trained and equipped to implement and support operational processes and procedures effectively, promoting proficiency and excellence.
• Provides guidance and direction to support, infrastructure, and platform professionals, facilitating their alignment with organizational objectives, fostering teamwork and collaboration.
• Holds responsibility for achieving results within the assigned competency area, including managing costs, optimizing methods, and fostering staff development, driving performance and accountability.Bachelor's / Master's Degree in Computer Science, Software Engineering, Information Technology or equivalent.
Over 10years of experience in areas such as Software Development, IT Operations or equivalent.
• Business Acumen
• Continuous Improvement
• Strategic Planning
• Project Management
• Cloud Technology
• SAFe Practices
• People Management
• Budget Management
• Operations Management
• Quality Assurance (QA)

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

Market Procurement Manager

Job Description Summary

Manages the strong relationship with local stakeholders and provides them the procurement expertise, using thorough understanding of Commodity Strategies, local market knowledge and supplier innovation, and thereby supports business in order to bring them the most efficient and cost effective solution. Ensuring all process compliances with local market statutory requirements, and procurement KPIs are met.

Key Responsibilities:

• You are responsible for 50 M€ spend through about 40 suppliers.
• Single Contributor Position locally. Focus given on diversity in large.
• Representing and positioning Procurement, interacting with key internal stakeholders, including Business Marketing Leader, Service Leader, Supplier Quality, Supply Chain Legal team
• Further defining the Procurement value proposal, balancing a project base approach into a Category and Project angle - promoting our standard catalog items.
• Ensuring 100% compliance through our own team according to local regulation, our Quality Management System, new Master Agreement, Cybersecurity directives and internal Policy.
• As part of continuous improvement, propose and/or implement key process changes within your team and facilitate with other stakeholders.
• Implementing, with the Market Procurement Leader, the procurement strategy, country specific.
• Boosting and maintaining the short and mid-term productivity funnel, focusing on P&L impact, leveraging Year Over Year productivity (e.g. supplier consolidation, redesign to cost approach, strong negotiations practices….).
• Maximizing assurance of supply to safeguard our revenue and customer satisfaction.
• Managing the supply base (segmentation, consolidation, risk management, performance monitoring).
• You are a part of the Integrated Supply Chain and Procurement organization. As such you will report into the Market Procurement Leader – International Markets.

You are part of The Integrated Supply Chain and Procurement organization, reporting to the Market Procurement Leader – International Markets.

You're the right fit if:

• A Bachelor’s degree, complemented with a last degree in Business, Supply chain or Procurement is preferred.
• A minimum of 5 years’ experience in Direct Procurement / Supply Chain/ Project Management within a Global matrix Medtech environment is needed as well.
• General skills in Medical Devices & 3rd Parties ~ Brand-Labelling equipment, associated service (Installation, repair, ….) and overall regulation is a real plus.
• Experience in sales/marketing/ project management is a plus. A first successful people management experience is appreciated as well – preference given in a multi-cultural context.
• Training / Certification in Lean or changing the acceleration process would help.
• Business acumen and constant inclusiveness, working hand with the Business Units, Market and Q&R management representatives.
• She/he will combine a “customer first” view together with no compromise on compliance.
• She/he will have influencing skills to challenge in a constructive way, legacy and status quo.
• Proficiency in Japanese and English (minimum TOEIC score of 750).

【休暇】初年度有給休暇　最大20日間（2年度～5年度 20日／6年度以降 25日 付与）、CareLeave（年間10日間）、Sick Leave（年間最大30日間）ほか

【研修制度】 各種オンライン研修、入社後のサポート研修あり

【その他】PhiliFlexポイント：72,000 ポイント（1ポイント＝1円）

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .

Your role:

Exciting opportunity to lead the team working on Cardiac and Endovascular registration projects for Philips Image-guided Therapy, which includes novel technologies integrated by therapeutic devices and visualization systems.

• Lead the Japan IGTD CA Team and all clinical studies and evidence development projects that the team is responsible for to proceed with the plan.
• Lead developing local clinical evidence development strategy and strategic discussion with the local RA team and other related stakeholders, including Business Unit, R&D, and Market Access & Reimbursement to accelerate projects and fast serve patients.
• Proactively identify risks within clinical evaluation strategies, plans, products and propose alternate approaches.
• Provide interpretation of local regulations to BU partners and ensure necessary requirements are fully deployed.
• Stay informed of new regulations and technologies relevant to endovascular therapeutics.
• Plan and execute clinical evidence development, GCP compliance review of foreign operated clinical trials, and PMS study as a condition of approval according to the regulations and aligned with local business needs.
• Manage interactions with MHLW/PMDA/KTLs and maintain a productive working relationship.
• Manage CRO services to ensure meeting with Philips’ business needs and operational policies.
• Review and approve clinical documentation according to the GCP/GPSP requirements.
• Oversee clinical administration activities.
• Report to the Head of Japan RA/CA as a solid line and the head of IGTD CA/MA as a dotted line.

You're the right fit if:

1. Experience.

• +10 years’ experience in clinical operation including medical device.
• Experience in the Study Manager role in medical device clinical studies and GCP compliance inspections by PMDA.
• Maintains extensive knowledge of the PMD act, GCP ordinance, GPSP ordinance, ICH guidelines, and ISO13485.
• Experience or working knowledge of EVT or any cardiovascular therapeutic medical devices.

2. Skills.

• Self-motivated and able to prioritize handling multiple tasks/responsibilities.
• Capable of thinking critically, logically, and strategically
• Bachelor of Science Degree (Master preferred)
• Fluent in Japanese and English

【就業場所】（雇入れ直後） 本社（麻布台ヒルズ）（変更の範囲）会社の定める就業場所

【休暇】初年度有給休暇　最大20日間（2年度～5年度 20日／6年度以降 25日 付与）、CareLeave（年間10日間）、Sick Leave（年間最大30日間）ほか

【研修制度】 各種オンライン研修、入社後のサポート研修あり

【その他】PhiliFlexポイント：72,000 ポイント（1ポイント＝1円）

About Philips• Learn more about .
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• Learn more about .

As a, will be responsible for supporting Sleep- Respiratory Care Software activity in UKI & France. On a daily basis you will manage different projects for our business customers regarding software malfunctions and user-experience issues.

Your role:

• Managing projects for Business customers of Philips

• Providing answers to customers' requests (2nd line support)

• Escalate when required to Software development

• Provides guidance and training to the service organization

• Shares knowledge with service organization and helps to keep knowledge base up to date.

You're the right fit if:

• 2- 4 years related experience in technical support or engineer support

• Experience in working with Software uploaded on medical or production devices - must have

• Native (or neat native) French & Fluent English

• Degree in Computer Science, Computer Engineering, or a related field

• Strong communication and organizational skills with a commercial approach

• Experience in client-facing roles

• Technical mindset

• IT Knowledge & experience in supporting various software

Our benefits:

• Employment contract

• Hybrid way of working (3 days per week at office in Lodz)

• Support in relocation

• Annual bonus based on performance achieved

• Private medical care with the option to extend it to family members

• Benefit System cards

• Discount for Philips’ products

• Wide variety of training & learning opportunities

• Promotion of a healthy lifestyle in the office

• Employee Assistance Program

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .