QRA Manager – Tokyo, Japan

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
The Quality and Regulatory Affairs (QRA) Manager – Japan is responsible for leading regulatory strategy, quality compliance, and post-market activities for medical devices marketed in Japan.

This role ensures compliance with Japanese medical device regulations including the Pharmaceutical and Medical Device Act (PMD Act), QMS Ministerial Ordinance, and applicable international standards such as ISO 13485.
The QRA Manager serves as the key interface with PMDA and MHLW, overseeing product registrations, regulatory lifecycle management, post-market quality activities, and the maintenance of an effective Quality Management System.

This position plays a critical role in ensuring product compliance throughout the entire lifecycle—from product registration to post-market surveillance and field actions.

Regulatory Responsibilities

Regulatory Strategy & Product Registration
• Develop and execute regulatory strategies to support product registrations and lifecycle management in Japan.
• Lead preparation and submission of regulatory applications including Shonin, Ninsho, and Todokede.
• Ensure timely regulatory approvals aligned with business objectives and product launch timelines.
• Manage regulatory lifecycle activities including product renewals and change submissions.

Regulatory Authority Interaction
• Serve as the primary contact with PMDA and MHLW.
• Lead regulatory consultations, meetings, and communications with regulatory authorities.
• Manage responses to regulatory questions and additional information requests during regulatory reviews.

Regulatory Intelligence
• Monitor and interpret regulatory developments in Japan including: PMD Act, QMS Ministerial Ordinance, and Regulatory guidance and standards
• Assess impact of regulatory changes on current products and pipeline development.
• Provide regulatory guidance to cross-functional teams.

Change Management
• Evaluate regulatory impact of product, manufacturing, labeling, or supplier changes.
• Determine appropriate regulatory pathways for product changes.
• Ensure compliance with regulatory requirements for product modifications.

Reimbursement & Market Access Support
• Support reimbursement submissions and interactions related to B1/B2/B3/C1/C2 categories.
• Collaborate with market access teams to support product commercialization.

Promotional Review
• Review advertising and promotional materials to ensure compliance with Japanese regulatory requirements.
• Ensure promotional claims are consistent with approved indications.

Quality Responsibilities

Quality Management System (QMS)
• Maintain and ensure compliance with the company Quality Management System in accordance with Japan QMS Ministerial Ordinance and ISO 13485.
• Ensure proper implementation and maintenance of quality procedures and documentation.
• Support internal and external audits including regulatory inspections.

Complaint Handling & Vigilance
• Oversee the complaint management process for products marketed in Japan.
• Ensure timely investigation, documentation, and resolution of customer complaints.
• Evaluate complaints for potential reportable events and manage required regulatory reporting.

Post-Market Surveillance (PMS)
• Support and manage post-market surveillance activities in accordance with regulatory requirements.
• Monitor product performance and safety trends in the market.
• Ensure appropriate escalation and risk assessment when safety concerns arise.

Recall & Field Safety Actions
• Lead and coordinate product recall and field safety corrective actions when necessary.
• Ensure timely communication with regulatory authorities, distributors, and healthcare institutions.
• Ensure compliance with regulatory reporting and documentation requirements.

Supplier & Manufacturer Quality Oversight
• Maintain quality oversight of contract manufacturers and suppliers.
• Ensure supplier qualification, monitoring, and quality agreements are maintained.
• Participate in supplier audits and quality performance evaluations.

Distribution & Import Quality Compliance
• Ensure appropriate quality controls for imported medical devices.
• Maintain distribution traceability and product release documentation.

Education & Experience

Education
• Bachelor’s degree in Science, Engineering, or a related field
• Advanced degree preferred.

Experience

• 10+ years of experience in Regulatory Affairs and/or Quality Assurance in the medical device industry
• Experience with PMDA regulatory submissions
• Experience supporting Class III or IV medical devices preferred
• Experience with cardiovascular or interventional devices preferred

Preferred Qualifications
• Experience serving as Marketing Authorization Holder (MAH) SOKATSU
• Experience as Domestic Quality Manager (KOKUNAI HINSEKI)

Knowledge & Skills
• Strong knowledge of Japanese medical device regulations and PMDA processes
• Expertise in Quality Management Systems and ISO 13485
• Experience in complaint handling, vigilance reporting, and recall management
• Strong project management and cross-functional collaboration skills
• Excellent communication skills in Japanese and English

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