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/A

In 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