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About the Role

ZEISS is a global technology leader in optics and optoelectronics. We are seeking a Regulatory Affairs professional to manage the entire scope of pharmaceutical affairs (Class I-III) in Japan. This role involves creating and managing documentation for medical device approvals, developing regulatory strategies in consultation with the PMDA, and securing approvals within schedule and budget.

Responsibilities

• Create and manage documentation for medical device approvals in Japan.
• Develop regulatory strategies in consultation and negotiation with the PMDA.
• Obtain approvals within schedule and budget by utilizing internal and/or external resources.
• Maintain business licenses and approvals.
• Prepare application documents in Japan.
• Understand PMD and related laws and regulations.
• Collect product information and development documents from foreign manufacturers.
• Formulate RA strategies, including consultation and negotiation with PMDA.
• Coordinate with internal departments and foreign manufacturers to prepare application documents.
• Respond to reviews and investigations of submitted application documents by regulatory authorities.
• Submit application documents to regulatory authorities.
• Coordinate with internal departments and overseas manufacturers to respond to inquiries and investigations regarding submitted documents.
• Obtain approvals within deadlines and budget.
• Maintain business licenses and approvals.
• Provide post-approval support.
• Collaborate with quality and safety departments.
• Review customer-facing documents (e.g., marketing brochures).
• Manage changes.
• Handle insurance application processes.

Requirements

• 3+ years of experience in regulatory affairs for Class II or higher medical devices or pharmaceuticals.
• 3+ years of experience in regulatory affairs for Class II or higher active medical devices.
• Practical experience in preparing and submitting applications for medical devices or pharmaceuticals.
• Knowledge of the Pharmaceuticals and Medical Devices Act and compliance awareness.
• Practical experience with PMDA consultations.
• English proficiency (reading, writing, and speaking sufficient for meeting participation).
• Logical thinking and writing skills.
• Proactive communication skills.
• Global mindset.
• Risk management activities.
• Practical experience in preparing and submitting applications for active medical devices.
• Practical experience in quality-related work.
• Knowledge of neurosurgery.
• Knowledge of ophthalmology.

Skills

• English skills (reading, writing, speaking)
• Logical thinking
• Logical writing
• Proactive communication
• Global perspective
• Risk management

Location

• Japan

Work Type

• Full-time

Experience Level

• 3+ years

Benefits

• Paid time off (14 days initially, increasing to 21-25 days based on tenure)
• Approximately 125 annual holidays (weekends, public holidays, year-end/new year)
• Special paid leave for congratulations and condolences
• Commuting allowance (up to 50,000 JPY)
• Retirement plan
• Defined contribution pension plan
• Cafeteria points system
• Condolence money
• Employment insurance
• Workers' accident compensation insurance
• Health insurance
• Group term life insurance
• Employee welfare club membership
• Discount on household medicines
• Influenza vaccination subsidy
• Discount on eyeglasses purchase
• Company club activities

About the Company

• ZEISS Group originated from a precision instrument and optics workshop founded in Jena, Germany in 1846.
• ZEISS Japan was established in 1911 and has approximately 400 employees across five locations.
• ZEISS Japan partners with industries including semiconductor, automotive, mechanical engineering, biomedical research, and medical technology.
• ZEISS is also a leading manufacturer of eyeglass lenses, camera lenses, and binoculars.
• We are a global technology leader in optics and optoelectronics.
• Our employees are setting the pace through innovations and enabling outstanding achievements.
• We offer a modern setting with opportunities for development, where expertise and team spirit are paramount.
• Our long-term goal, supported by the Carl Zeiss Foundation, is to advance science and society together.

Equal Opportunity

• Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.