Specialist, RA
Share
Job Location:
Monthly Salary:
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
The Regulatory Affairs Specialist supports global regulatory compliance for in vitro diagnostic (IVD) products where the company acts as the Legal Manufacturer ensuring timely market access and adherence to international standards.
This role encompasses product registration launch change management and other regulatory activities such as site registration audit support documentation control and compliance with ISO 13485-based Quality Management System (QMS). The position requires close collaboration with internal teams and external stakeholders to maintain regulatory conformity and support global distribution.
- Prepare submit and track regulatory applications for product launches market expansion and registration renewals.
- Evaluate the regulatory impact of product changes and coordinate actions within change control processes.
- Ensure labeling compliance including managing translations and verifying regulatory requirements.
- Support interactions with regulatory authorities and Notified Bodies responding to inquiries and submitting required documentation.
- Assist with audits and inspections by providing regulatory documentation and responding to regulatory-related inquiries as a subject matter expert.
- Manage adverse event reporting and ensure timely communication with relevant departments.
- Monitor global regulatory changes and communicate updates with internal stakeholders.
- Maintain and update documentation required for product approvals and certifications.
- Conduct regulatory reviews within internal change control processes and collaborate with cross-functional teams.
- Strong English and Japanese communication skills (written and verbal)
- Experience in Regulatory Affairs for IVD or Medical Devices; typically 2 years preferred but equivalent experience considered
- Ability to collaborate effectively with cross-functional teams
- Understanding of regulatory requirements for IVD/Medical Devices
- Basic understanding of ISO 13485 and global QMS principles
- Bachelors degree in Life Sciences Engineering or related field (preferred)
- High attention to detail and strong documentation management skills
- Experience in building and maintaining Technical Files (e.g. IVDR CSDT STED)
- Hands-on experience with international product registrations and change submissions
- Project coordination or cross-functional collaboration experience
- Familiarity with risk management principles (ISO 14971)
- Strong technical writing skills for regulatory documentation
- Ability to monitor and interpret global regulatory changes (Regulatory Intelligence)
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-shi : 357 Nakahara Matsuhidai
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
