PRIMARY FUNCTION / OBJECTIVE
[Regulatory Compliance]
* Assess the published entire regulations for QMS and Regulatory related / Manage BAQP between Production site and Japan as MAH / Manage, retain FMR (Manufacturer registration) / Collaborating with RIS and AV-BU.
* Align with Global-RIS Team and harmonise the process.
* Manage the requirement under regulation (related to Product approval license, Physician’s training etc.).
* Manage and supervise the responsible group.
[Others]
Support the director and other members.
MAJOR RESPONSIBILITIES / ACCOUNTABILITY
[Regulatory Compliance under Quality Management System]
* Maintain the BAQP between Production site and Japan as MAH.
* Manage the reporting requirements for quality system changes, device listings, facility listings, and compliance-related events.
* Participate in the Regional / Local Management Review Meeting and present the related agenda for Regulatory Compliance.
[Quality Management System]
* Ensures that all activities are performed in compliance with quality system requirements.
* Responsibilities for consultation and negotiation as a contact window for Regulatory notification, Ordinance, Standards and so on related to the published regulations.
* Responsibilities for introducing requirements based on the regulation, notification/ordinance, and regulator’s instructions.
* Responsibilities for collect, assessment and review necessary information to plan ensuring appropriate action to be taken.
* Responsibilities for creating the assessment report of published notifications and report them within designated date.
* Responsibilities for manage progress and ensure completion of measures against impacted notification.
* Responsibilities for creating and maintaining records related to Regulatory Compliance tasks.
* Implement or manage to develop, maintain, or improve following main quality processes including sub-processes:
・Management Responsibility
・Purchasing Controls
・Change Management & Document Control
・Product Approval (Marketing processes)
・Production & Process Controls (Sales & Distribution)
・Improvement (Corrective and Preventive Action)
・Post Market Support
[Others]
* Develop and support implementation of impact goals and growth plan for the department members.
* Responsibilities for monitor the progress of group operations and provide appropriate leadership, advice and support to group members.
* Responsible for reporting the progress of group operations to managers.
* Perform operations as directed by your managers.
Note: The main duties and responsibilities describe the general overview and level of activities assigned to this position. This document does not contain the detail of every duty and responsibility required by the position.
FINANCIAL ACCOUNTABILITY (as applicable)
N/A
SUPERVISORY ACCOUNTABILITY (as applicable)
N/A
EDUCATION, EXPERIENCE, KNOWLEDGE/SKILLS
EDUCATION
Required minimum formal education
Completed a specialized course in physics, chemistry, biology, engineering, informatics, metallurgy, electricity, mechanics, pharmacy, medicine, or dentistry at a university.
More than 3 years, or worthy of experience of Quality officer, or Safety Officer, of MAH officer under PMD Act.
Preferred formal education
4 years university degree of medical, pharmacology, scientific or engineering related fields.
PROFESSIONAL EXPERIENCE
Minimum required professional experience
Engaged in Quality, Safety assurance work or Regulatory Affairs for 3 years or more at the Pharmaceutical or Medical Device company.
Preferred professional experience
Experiences in people management, or equivalent experience of project lead etc.
Legal / Certification requirements
N/A
KNOWLEDGE / SKILLS
Language Requirements
日本語 Japanese
ビジネスで使える英語スキル English for business usage
Product Knowledge
Good knowledge of clinical usage for Vascular products.
Quality System Knowledge
Sufficient Quality System knowledge of ISO13485, ISO related standard(9001, 140001) etc.
Manufacturing Knowledge
Good knowledge of product design and manufacturing process for Medical devices.
Business Knowledge
Portable/Transferable skills (Communication, Logical thinking, Presentation, Negotiation, and Problem solution skills)
Preferred: Good knowledge of logistics and supply chains of medical device.
Regulatory Knowledge
Sufficient knowledge of PMD Act. QMS and GVP.
Commercial Knowledge
Preferred: Good knowledge of business style of medical device(consignment sales).
IT Systems / Skills
Word, Excel, PowerPoint
Training / Certification
Preferred: Qualified Lead Auditor related ISO13485 etc.
Competencies
ビジネスの理解、周囲によい影響を与える、イノベーションを促進する、イニシアティブを取る、結果を出す、関係構築 Entrepreneurial Drive, Inspire Others, Drive Innovation, Take Initiative, Deliver Results, Building relationship
Other
N/A
#J-18808-Ljbffr