In this role, you have the opportunity to:
guide and support Business Groups, Japan Market and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
This role will report to the Head of Quality & Regulatory International Markets.
You are responsible for
Quality and regulatory in Japan Market.
Working in the medical industry, which brings much fulfillment, as well as unique challenges.
As part of Philips HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with regulatory agencies such as the Japan Govt/ Competent Authority.
Key areas of responsibilities (KARS) for this role include:
Lead and manage Q&R activities in the Japan market. This includes responsibilities for Post-Market Surveillance (PMS), the Quality Management System and dotted line responsivities for RA.
Quality officer responsibilities. (Element of 2020 PMD act renewal plan/PMD act)
Quality Officer has all the responsibility for the MAH activity under requirement of PMD act.
As the Quality officer he/she is responsible to supervise and prevent any potential illegal actions in the MAH.
Responsible for processing and administration of Customer Feedback & Complaints, Safety reporting, Medical Vigilance Reporting, coordination of FSN/FCO and interactions with local government agencies.
Responsible for the Deployment and Compliance to PMD act which required for product shipment and recall. QA manager has all the responsibility for product shipment to Japan market from the quality assurance perspective.
Quality Management Systems oversight, including deployment, Auditing, managing Corrective & Preventive actions (CAPA) and for the promotion of quality awareness.
Continuously measure, analyze and improve the performance of quality related KPIs in order drive business performance.
Foster a positive employee relations environment by promoting open communication, engagement and development of team members. Promote a culture of inclusiveness, trust, flexibility and teamwork.
Ensure collaboration by participating in and leading cross functional, global and Regional process improvement initiatives as deemed necessary to support the QMS. Support new business initiatives from a QMS maintenance.
Self starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
Must possess strong communication, project management and leadership skills as well as have the ability to manage multiple projects simultaneously
Capable of working as part of , or leading a multi-disciplined team.
You are a part of Philips Quality
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Clusters and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people.
You are excited by the unique professional challenges that our Quality Transformation presents, and have strong technical competencies, and demonstrate resilience to challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
Specific skill requirements for this role include:
Bachelor Degree (Life Science, Pharmaceutical, Medical Engineering, or similar technical discipline). Advanced degree preferred in technical or clinical field.
Management and strong leadership skills in a challenging working environment.
In depth knowledge of key requirements for Post Market Surveillance and experience interfacing with Japan regulatory bodies/health ministries.
Experience with managing product approval process in applicable markets and respective countries.
Must have strong knowledge of Japanese Regulations, awareness of ISO 13485, 9001, and 14971 (Risk management).
Ability to resolve complex issues in creative and effective ways and to introduce new
Strong interpersonal and communication skills at all levels in the organization
In return, we offer you
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
【就業時間】9:00-17:30 （管理職待遇となりますのでOvertime Exempt）
【休暇】 有給休暇：初年度最大20日間（入社月により変動します）、Care Leave（年間10日間付与）、Sick Leaveほか