|職務内容||Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
For the Abbott Rapid Diagnostics Infectious Disease - Emerging Markets Business Unit, be responsible for the management/strategy of RA activities in the defined geography relating to
〇 distributed products in the commercial businesses; whether owned directly by ARDx or owned by Distributors
〇 work closely with site Quality Affairs to ensure product compliance with registrations and regulations
This job function has accountability for complying with the applicable elements of Global Quality and the ARDx Quality Management System (QMS).
This job description will be reviewed periodically and is subject to change by management. The position of Regulatory Affairs Manager is within our IDEM Business Unit located at our Chiba Plant, in Japan.
〇 Initiate NPI submission strategy, planning (MHLW, TUV, WHO, others)
〇 Develops registration plans for assigned products in collaboration with regional Regulatory Affairs based staff and manufacturing site cross functional colleagues (QA, Supply Chain, Operations, etc)
〇 Maintain also drive licensing (ISO13485, Japan-GMP, etc.) tasks together with QRC team
〇 Participate design change project and provide the status update to cross functional colleagues (R&D, TechSupport, QA, Supply Chain, Operations, etc)
〇 Ensures execution of registrations of products in alignment with regulatory plans
〇 Maintain RA database such as GRID to Keep the most latest RA status
〇 Actively participates in short and long-range planning including the development of Key Performance Indicators
〇 Promotes awareness of regulatory and customer requirements throughout the organization, including through organized training programmed
〇 Directly manages registration activities with Notified Bodies in Europe and the WHO
〇 Supports sites in contact with National Regulatory Agencies
〇 Represents manufacturing site as RA SME at relevant leadership meetings
〇 Represents manufacturing site as RA SME in relevant Industry forums
〇 Supports business operations in adverse event reporting
〇 Supporting business operations in product modification reporting
〇 Facilitates gathering of regulatory intelligence
〇 Upholds the company’s core values
|応募資格||【BASIC QUALIFICATIONS | EDUCATION】
〇 BSc or equivalent.
〇 Training in Regulatory Affairs
〇 Relevant experience at a senior level
〇 A minimum of 8 years’ experience in areas directly relevant to the position
〇 Advanced understanding of compliance, cGMP and product development.
〇 Able to prepare, analyze and present Key Performance Indicators (KPIs).
〇 Process Excellence certified (Yellow Belt/Green Belt).
〇 Analytical/Problem Solving Skills (e.g. DMAIC, statistical techniques, risk analysis)
〇 Excellent written and oral communication skills with ability to interact with all levels leader-ship, internal/external customers and third-party vendors.
〇 Experience in rapid diagnostics industry