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Updated 2024-05-14
Activated 2024-05-14
Activated 2024-05-14
RA Manager at New Market Entry Global Medical Device Startup
- Recruiter
- Manager Level
| This posting is managed by: | Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社 |
|---|---|
| Company Name | Company is not publicly visible |
| Job Type |
 Medical/Pharmaceutical/Bio/Fabric/Food - Patent |
| Industry | Medical devices |
| Location |
Asia
Japan
|
| Job Description |
Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market. Description * Lead in regulatory submissions for company products to obtain product approval * Develop effective regulatory strategies and collaborate global stakeholders to align business growth * Communicate, negotiate, develop key relationships with health authorities (PMDA, MHLW, etc.) * Be the key person to share necessary regulations/compliance requirements in Japan * Manage any regulatory changes, procedures, if required * Participate in internal and external audits Profile * University degree in scientific or related field * Fluency in English and Japanese (Non-native level speakers will not be selected) * Experience in successful submissions for approval for class III medical device products in Japan * Ability to work independently with collaboration with global stakeholders * Develop key relationships with local health authorities (ex. PMDA, MHLW, prefectural bodies) * Ability to travel globally when required Job Offer * Competitive salaries and benefits * Fully remote working style * Be the first person in Japan to launch the business * Work with industry leaders who are solving unmet medical needs * Ability to travel internationally Page Group Japan is acting as an Employment Agency in relation to this vacancy. |
| Company Info |
* Global medical device company operating in 40 countries around the globe * Specializing in up to class III products focusing in the orthopaedics area * 30% increase in growth year on year globally * Prides themselves on innovation and cutting-edge products for various unmet medical needs * Globalized culture collaborating with patients, doctors, and other healthcare professionals worldwide |
| English Level | Business Conversation Level (TOEIC 735-860) |
| Japanese Level | Native Level |
| Salary | JPY - Japanese Yen JPY 14000K - JPY 20000K |
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Recruiter
Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
