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 device Regulatory Affairs including submission with clinical data, 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 on B1/B2/B3/C1 and C2 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 ISO
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
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