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About the Role

Radiometer, a Danaher operating company, is seeking a Specialist, Commercial RAQA to ensure compliance with GVP requirements and maintain the quality and safety of marketed medical devices and IVD products. This role serves as the Safety Management Officer under the PMD Act and involves partnering with key stakeholders to uphold product integrity.

Responsibilities

• Serve as the Safety Management Officer under the PMD Act, ensuring compliance with applicable GVP requirements.
• Partner with key stakeholders to maintain the quality and safety of marketed medical devices and IVD products.
• Collect and manage safety information for products in domestic and international markets.
• Plan and manage necessary measures for the Japanese market.
• Ensure all internal activities comply with Japanese regulations, ISO 13485, and global quality standards.
• Pre-verify promotional tools, sales materials, and related activities from regulatory and safety perspectives.
• Collaborate with the Total Quality Management Representative and Domestic Quality Management Representative to ensure post-market product quality and safety.
• Manage and maintain appropriate business operations as a responsible manager for medical device and/or in-vitro diagnostic reagent manufacturing, sales, etc., at the business site.
• Lead or support regulatory inspections and audits by authorities such as PMDA and the Tokyo Metropolitan Government, and appropriately complete corrective actions (CAPA).
• Participate in activities to maintain and improve the Japanese Quality Management System (QMS) in accordance with ISO 13485, QMS Ordinance, and internal quality policies, performing practical tasks as the person in charge.
• Execute practical tasks for complaint handling, recalls, safety management (Vigilance), and shipment decisions under the direction of the Total Quality Management Representative.
• Monitor product quality performance and market feedback, analyze defect trends, and report to global stakeholders.
• Collaborate with global R&D and manufacturing sites to contribute to root cause identification and the promotion of design and process improvements.
• Handle regulatory compliance tasks, including fair trade, labeling/advertising review, and promotional material review.
• Promote risk-based decision-making and continuous improvement, contributing to the fostering of a compliance culture.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, or a related science field.
• Must possess a Pharmacist license.
• Over 5 years of experience in Quality Assurance, Regulatory Affairs, or Safety Management within the medical device or in-vitro diagnostic reagent industry.
• Basic to intermediate knowledge of the Pharmaceutical and Medical Device Act (Yakkiho), ISO 13485, QMS Ordinance, and GVP.
• High communication skills in Japanese.
• High ethical standards and a strong sense of responsibility, with the ability to make proposals based on appropriate judgment.
• Strategic thinking and agility, balancing compliance and business needs.
• Ability to build collaborative relationships in cross-departmental teams and execute tasks with high motivation.
• Ability to communicate clearly and effectively with internal and external stakeholders.
• Awareness of continuous improvement and the ability to proactively foster a culture of quality and trust.
• High stress tolerance and the ability to remain calm under pressure, such as during inspections or organizational changes.

Skills

• Quality Assurance
• Regulatory Affairs
• Safety Management
• GVP requirements
• ISO 13485
• QMS Ordinance
• Pharmaceutical and Medical Device Act (Yakkiho)
• Communication

Location

• Tokyo
• Onsite

Work Type

• Onsite

Experience Level

• 5+ years

Education Level

• Bachelor's or Master's degree
• Pharmacist license

Salary/Compensations

• 4.2 to 7.7 million JPY (including semi-annual fixed bonuses)
• Performance bonus: 10% of base salary (paid based on company and individual performance)

Benefits

• Group life insurance
• Long-term disability income insurance
• Benefit Premium
• Health check-up subsidy
• Condolence and congratulatory money
• Club activities
• Health insurance
• Employees' Pension Insurance
• Employment insurance
• Workers' accident compensation insurance
• Defined benefit corporate pension (cash balance plan)
• Defined contribution pension
• Flextime system (no core time)
• Remote work system (available to some employees)

About the Company

• Radiometer is one of Danaher's operating companies, focused on improving global healthcare with reliable, fast, and easy patient diagnoses.
• Danaher is a global science and technology innovator committed to accelerating the real-life impact of science and technology.
• Danaher partners with customers to solve their most complex challenges, architecting solutions that bring the power of science to life.