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: