We are hiring

We are currently hiring professionals with hands-on experience in regulatory submissions for medical devices and in vitro diagnostics (IVDs) in Japan and the United States, in line with our business expansion.**

We welcome freelancers and those seeking side work. 🌟 We also actively encourage applications from candidates aged 60 and above. If you are interested, please feel free to contact us.

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■ Key Responsibilities

* Overall support for FDA and PMDA regulatory submissions
* Regulatory research, documentation, and submission support

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■ Requirements

* Hands-on experience in PMDA approval applications for medical devices and/or IVDs
* Strong knowledge of Japanese regulatory requirements and FDA regulations
* Practical experience with FDA submissions
* Experience in medical writing
* Proficiency in reading and writing English for business purposes

 

■ Preferred Qualifications

* Ability to communicate effectively in English

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■ Number of Positions

* A few openings

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■ Compensation

* To be discussed based on experience and skills

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■ Why Join Us

* Opportunities for international business travel (U.S., Europe, and Asia)
* Flexible working arrangements
* Opportunity to leverage your expertise in a global environment

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Project Manager Position

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■ Key Responsibilities

* Overall project management (schedule, resources, and risk management)
* Client communication, requirement definition, and preparation of materials
* Coordination and management of project teams
* Research on global regulatory requirements and reporting to clients
* Administrative procedures related to PMDA and FDA submissions
* Document management
* Handling inquiries and other related tasks

 

 ■ Requirements

* At least 2 years of hands-on project management experience
* Strong written communication skills in English (emails, documentation, etc.)
* Solid IT knowledge and skills, with the ability to leverage systems and tools for improving efficiency and solving business challenges

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■ Number of Positions

* 1

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 ■ Compensation

To be discussed based on experience and skills

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■ Why Join Us

* Opportunities for international business travel (U.S., Europe, and Asia)
* Flexible working arrangements
* Opportunity to leverage your expertise in a global environment

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How to Apply

Please apply using one of the following methods:

* Email: Please contact us at [info@iaccessconsultant.com](mailto:info@iaccessconsultant.com)
* Contact form: Apply via our website contact form