About this role
JOB DESCRIPTION: Abbott Diagnostics Medical Co., Ltd. supply variety of rapid diagnostics products globally.
The Regulatory Affairs Specialist provides a support role to the physical and legal manufacturing site at Chiba, Japan.
This position provides regulatory expertise in the IVD / Medical Device area to execute regulatory activities with cross functional on site or global teams including but not limited to: IVDR teams, EU Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to and after product release.
• Implement regulatory activities to ensure
• regulatory requirements compliance and earliest possible introduction of product(s) • regulatory impacts for post market change management activities
• Global registration of change associated with the key project • Update of technical file and labelling associated with the key project • Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications. • Provide technical expertise for site certifications and quality management system audits. • Provides input and comment on regulations and standards which may affect division products. • Implement processes and activities involved with obtaining and maintaining product release authorization and release of product to specified geographies. • Implement Regulatory Affairs process and activities within the Medical Device Reporting / vigilance process; and report timely to regulatory authorities, notified body, and related stakeholders or organizations. • Implement labeling process and activities during product life cycle.
The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: ID Infectious Disease LOCATION: Japan > Matsudo : 357 Nakahara, Matsuhidai ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable