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About the Role
ZEISS Japan is seeking a Regulatory Affairs professional to manage medical device submissions (Class I) in Japan, develop RA strategies for new product introductions, and ensure regulatory approvals within schedule and budget. This role involves maintaining business permits and approvals, and reviewing promotional materials.
Responsibilities
- Manage medical device regulatory submissions (Class I) in Japan.
- Develop RA strategies for new product introductions.
- Achieve regulatory approvals (notifications) within schedule and budget utilizing internal and/or external resources.
- Maintain and manage business permits and approvals.
- Conduct regulatory reviews of promotional materials.
Requirements
- Over 3 years of experience in regulatory affairs for Class 1 and Class 2 (or higher) medical devices.
- Practical experience in submitting applications for approval of medical devices or pharmaceuticals.
- Knowledge of the Pharmaceutical and Medical Device Act (PMD Act) and compliance awareness.
- Practical experience with PMDA consultations.
- English proficiency (reading, writing, and conversational ability to participate in meetings).
- Logical thinking and logical writing skills.
- Proactive communication skills.
- Global mindset.
Skills
- Regulatory Affairs
- Medical Device Submissions
- RA Strategy Development
- PMDA Consultation
- English
- Logical Thinking
- Communication
- Global Perspective
Location
- Tokyo Office
- Nationwide locations (scope of change)
Work Type
- Full-time
- Onsite
Experience Level
- 3+ years
Salary/Compensations
- ¥5,300,000 - ¥9,400,000 (including bonuses and various allowances, depending on skills and experience)
- Monthly salary: ¥460,000 - ¥620,000
Benefits
- Paid leave: 2-14 days in the first year, increasing to 21-25 days based on years of service.
- Holidays: Approximately 125 days (weekends, national holidays, New Year's holidays from Dec 29 - Jan 4), plus special congratulatory/condolence leave.
- Work hours: 9:00-17:30 (including 1-hour break, 7.5 working hours). Overtime may be required and is compensated.
- Welfare: Congratulatory/condolence money, retirement plan, defined contribution pension plan, cafeteria point system.
- Commuting allowance: Up to ¥50,000.
- Insurance: Employment insurance, workers' accident compensation insurance, health insurance, group term life insurance.
- Additional benefits: Welfare club membership, discount on household medicines, influenza vaccination subsidy, discount on eyeglasses.
- Internal club activities.
- Smoking cessation measures: No smoking on premises.
About the Company
- ZEISS Group originated from a precision instrument and optics workshop founded in Jena, Germany in 1846 by Carl Zeiss.
- ZEISS Japan was established in 1911 and currently has approximately 400 employees across five locations, providing sales and services.
- ZEISS Japan partners in semiconductors, automotive, mechanical engineering, biomedical research, and medical technology, and is a leading manufacturer of eyeglass lenses, camera lenses, and binoculars.