Job Description
**概要**
**THE COMPANY and BUSINESS**
With a more than 60-year history of pioneering products to treat millions of patients, Cordis is a worldwide leader in the development and manufacturing of interventional vascular technology. Cordis established a legacy of high-quality and less-invasive cardiovascular products and built a strong global footprint with operations in countries around the world. But we’re not stopping there.
**_We are innovators at heart_**
In March of 2021, private equity firm Helman & Friedman announced the purchase of Cordis in recognition of its enormous growth potential, committing to a $300 million investment to accelerate innovation. Building on our storied brand, we are unleashing our potential to be a $10 billion leader and transform the market bringing new technology through bold action at speed.
**_People are the heart of our business_**
We are teammates, not just employees. Empowered to act as owners, our teammates deliver excellence in service of our mission: to delight our customers. Cordis is both a place to fulfill your career aspirations and a bigger purpose. Each teammate contributes to the wellbeing of millions of patients who enjoy healthier and longer lives as a direct result.
Diversity and inclusion are foundational to our values and successes. The richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately the lives of our patients.
**職責**
**_Job Summary_**
This position will be responsible for leading all medical device Regulatory Affairs activities which include product submissions, develop regulatory strategies, change assessments, commercial supports, compliance related activities, systems/process improvements and other responsibilities aligned with medical device regulation and business goals.
Keep the good relationship with related authorization agencies.
+ Develop and implement regulatory strategy and suitable yearly plan to ensure the actual registration operation per set timeline for all types of product registrations (includes product with clinical data)
+ Author product submission/notification, correspondent letter to authority
+ Directly communicate with local authority (MHLW/PMDA) upon implementing regulatory strategy and correspondent on submissions.
+ Monitor regulation, policy and standard changes from government authorities that have impact to company’s products.
+ Assess regulatory impact on various product/process change
+ Submit partial changes or change notifications to approved products to PMDA as required.
+ Author reimbursement submission document
+ Review and approve advertising/promotional material to assure compliance with governing advertising/promotion
+ Collaborate with necessary internal/external source to proceed assigned projects
+ Attend related industry meetings to gather latest information and input necessary company opinion with internal cross functional alignment
+ Performs other duties as needed
**資格**
**_Qualifications_**
**Education & Experience**
+ Bachelors in related field or equivalent work experience, Science and Engineering background preferred
+ 7+ years’ experience in medical deviceRegulatoryAffairs including submission with clinicaldata, experience working with PTA-related products (CLASS-IV) is preferred
+ Prior experience authoring and receiving approval of medical device SHONIN submission document with clinical data, experience working with PTA-related products is preferred
+ Prior experience onB1/B2/B3/C1andC2 reimbursement submission preferred
+ Knowledge and experience with manufacturing control and quality control under requirements of QMS ministry ordinance in medical devices industry. (Experience as a general manager of MAH(SOKATSU)or a domestic quality manager(KOKUNAI-HINSEKI)required by PMD-Act are even more desirable)
+ Knowledges and experiences with ISO13485(2016)
**Skills**
+ Comprehensive knowledge of current regulations and guidelines
+ Fluent in Japanese/English reading, writing and communication
+ Familiar with MS Office applications
+ Strong project management skills
+ Ability to adapt constant changes in fast pace
\#LI-DW1
**オプション**
この仕事にオンラインで応募 応募
共有
この仕事を友達に電子メールで送信 紹介
ニュースフィードで共有
応募に関するよくある質問（FAQ） (https://icims.help/candidate-faq)
iCIMS 運営のソフトウェア
**勤務地** _JP-Tokyo_
**ID** _2025-12047_
**カテゴリ** _Quality/Regulatory_
**Position Type** _Regular Full-Time_
CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact [email protected]
**THE COMPANY and BUSINESS**
With a more than 60-year history of pioneering products to treat millions of patients, Cordis is a worldwide leader in the development and manufacturing of interventional vascular technology. Cordis established a legacy of high-quality and less-invasive cardiovascular products and built a strong global footprint with operations in countries around the world. But we’re not stopping there.
**_We are innovators at heart_**
In March of 2021, private equity firm Helman & Friedman announced the purchase of Cordis in recognition of its enormous growth potential, committing to a $300 million investment to accelerate innovation. Building on our storied brand, we are unleashing our potential to be a $10 billion leader and transform the market bringing new technology through bold action at speed.
**_People are the heart of our business_**
We are teammates, not just employees. Empowered to act as owners, our teammates deliver excellence in service of our mission: to delight our customers. Cordis is both a place to fulfill your career aspirations and a bigger purpose. Each teammate contributes to the wellbeing of millions of patients who enjoy healthier and longer lives as a direct result.
Diversity and inclusion are foundational to our values and successes. The richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately the lives of our patients.
**職責**
**_Job Summary_**
This position will be responsible for leading all medical device Regulatory Affairs activities which include product submissions, develop regulatory strategies, change assessments, commercial supports, compliance related activities, systems/process improvements and other responsibilities aligned with medical device regulation and business goals.
Keep the good relationship with related authorization agencies.
+ Develop and implement regulatory strategy and suitable yearly plan to ensure the actual registration operation per set timeline for all types of product registrations (includes product with clinical data)
+ Author product submission/notification, correspondent letter to authority
+ Directly communicate with local authority (MHLW/PMDA) upon implementing regulatory strategy and correspondent on submissions.
+ Monitor regulation, policy and standard changes from government authorities that have impact to company’s products.
+ Assess regulatory impact on various product/process change
+ Submit partial changes or change notifications to approved products to PMDA as required.
+ Author reimbursement submission document
+ Review and approve advertising/promotional material to assure compliance with governing advertising/promotion
+ Collaborate with necessary internal/external source to proceed assigned projects
+ Attend related industry meetings to gather latest information and input necessary company opinion with internal cross functional alignment
+ Performs other duties as needed
**資格**
**_Qualifications_**
**Education & Experience**
+ Bachelors in related field or equivalent work experience, Science and Engineering background preferred
+ 7+ years’ experience in medical deviceRegulatoryAffairs including submission with clinicaldata, experience working with PTA-related products (CLASS-IV) is preferred
+ Prior experience authoring and receiving approval of medical device SHONIN submission document with clinical data, experience working with PTA-related products is preferred
+ Prior experience onB1/B2/B3/C1andC2 reimbursement submission preferred
+ Knowledge and experience with manufacturing control and quality control under requirements of QMS ministry ordinance in medical devices industry. (Experience as a general manager of MAH(SOKATSU)or a domestic quality manager(KOKUNAI-HINSEKI)required by PMD-Act are even more desirable)
+ Knowledges and experiences with ISO13485(2016)
**Skills**
+ Comprehensive knowledge of current regulations and guidelines
+ Fluent in Japanese/English reading, writing and communication
+ Familiar with MS Office applications
+ Strong project management skills
+ Ability to adapt constant changes in fast pace
\#LI-DW1
**オプション**
この仕事にオンラインで応募 応募
共有
この仕事を友達に電子メールで送信 紹介
ニュースフィードで共有
応募に関するよくある質問（FAQ） (https://icims.help/candidate-faq)
iCIMS 運営のソフトウェア
**勤務地** _JP-Tokyo_
**ID** _2025-12047_
**カテゴリ** _Quality/Regulatory_
**Position Type** _Regular Full-Time_
CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact [email protected]
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