JOB DESCRIPTION:

Position Summary:

The Regulatory Affairs Senior Specialist is responsible for executing and coordinating global regulatory activities for in vitro Diagnostics (IVD) products for which the company serves as the Legal Manufacturer. The role supports product launches, market expansion, and lifecycle management by ensuring compliance with applicable global regulatory requirements.

Key responsibilities

• Execute regulatory activities to support product launches, market expansion, and maintenance of existing approvals
• Assess regulatory impact of product and labeling changes and support related change control activities
• Coordinate regulatory documentation and labeling updates required to sustain product compliance
• Support communications with regulatory authorities and Notified Bodies, as needed
• Monitor regulatory and standards changes and share relevant updates internally
• Represent Regulatory Affairs in cross-functional projects
• Perform other Regulatory Affairs related activities as required

Required Qualifications Regulatory Experience

• Experience in regulatory activities for IVD products or related medical devices
• Practical experience with regulatory requirements in at least one region (e.g. EU, APAC, Latin America)
• Experience interacting with regulatory authorities and/or Notified Bodies

Execution & Coordination

• Ability to independently manage regulatory activities and coordinate with internal stakeholders at a Senior Specialist level
• Experience maintaining documentation for product approvals and certifications

Communication

• Ability to collaborate effectively with regulatory authorities and internal cross‑functional teams
• Proficiency in English for regulatory documentation and professional communication

Analytical Ability

• Ability to assess regulatory impact of product or labeling changes
• Sound judgment in regulatory decision‑making, including adverse event handling

Flexibility & Learning

• Ability to adapt to regulatory changes
• Motivation to continuously develop regulatory knowledge and apply it in practice

Preferred / Advantage

• Experience in global regulatory project coordination
• Experience with international product registrations
• Experience interacting with global regulatory stakeholders
• Strong regulatory writing skills

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