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
Provide support on a range of medical device and activities which include product submissions, implement regulatory strategies, change assessments, commercial supports, and other responsibilities aligned with medical device regulation and business goals. Keep the good relationships with related authorization agencies. Furthermore, will be responsible for supporting the manufacturing and quality control of medical devices that have been manufactured overseas and imported into Japan after obtaining approval.
- Implement regulatory strategy and suitable yearly plan to ensure the actual registration operation per set timeline for all types of product registrations
- Author product submission dossier and correspondent letters to authorities
- Directly communicate with competent authorities upon implementing regulatory strategies on submissions.
- Monitor regulation, policy and standard changes from government authorities that have impact to company's products.
- Assess regulatory impacts on various product/process changes
- Collaborate with necessary internal/external source to proceed assigned projects
- Attend related industry meetings to gather latest information and input necessary company opinions with internal cross functional alignment
- Tasks related to domestic manufacturers control and product quality control
- Perform other duties as needed
資格
Qualifications
Education & Experience
- Bachelor's Degree or above in related field
- 2-3 years' experience in medical device Regulatory Affairs, experience working with Percutaneous Transluminal Angioplasty -related products (CLASS-Ⅲ or IV) is preferred
- Profound knowledge in cardiovascular industry is a plus
- Knowledge and experience with manufacturing control and quality control under requirements of QMS ministry ordinance and ISO in medical devices industry.
Skills
- Comprehensive knowledge of current regulations and guidelines
- Fluent in English reading, writing and oral communications
- Familiar with MS Office applications
- Strong project management skills
- Ability to adapt constant changes in fast pace
#LI-DW1
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