Senior Regulatory Affairs Specialist

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. 

Job Summary  

Provide support on a range of medical device and 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
• 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

Qualifications

Education & Experience

• Bachelor’s Degree in related field, Science background preferred
• 7+ years’ experience in Regulatory Affairs for medical devices including clinical data
• Experience in authoring and obtaining approval for medical device regulatory applications in the IVR field
• Prior experience on C1/C2 reimbursement submission preferred

Skills

• Comprehensive knowledge of regulations and guidelines related to medical device approval application procedures
• 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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