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About the Role

Radiometer, a Danaher operating company, is seeking a Specialist, Commercial RAQA to serve as the Safety Management Officer under the PMD Act. This role ensures compliance with GVP requirements and maintains the quality and safety of marketed medical devices and IVD products. You will work within a culture of belonging and continuous improvement, contributing to innovations that accelerate the impact of science and technology in life sciences, diagnostics, and biotechnology.

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 relevant products domestically and internationally.
Plan and manage necessary measures for the Japanese market.
Ensure all internal activities comply with Japanese regulations, ISO 13485, and global quality standards.
Pre-screen promotional tools, sales materials, and related activities for regulatory compliance and safety.
Manage post-marketed product quality and safety in collaboration with the General Manager of Manufacturing and Quality Assurance.
Act as the business operator (responsible technician, manufacturing manager, sales office manager, chief pharmacist, etc.) for medical device and/or in-vitro diagnostic product manufacturing and sales businesses at the work location, and manage related operations and business formats.
Lead or support regulatory authority inspections and audits (PMDA, Tokyo Metropolitan Government, etc.) and appropriately complete corrective actions (CAPA).
Participate in maintaining and improving the Japanese Quality Management System (QMS) in accordance with ISO 13485, QMS Ordinance, and internal quality policies, performing practical tasks as the responsible person.
Execute practical tasks related to complaint handling, recalls, safety management (Vigilance), and shipment decisions under the direction of the General Manager of Manufacturing.
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.
Possession of a Japanese Pharmacist License (required).
5+ years of experience in Quality Assurance, Regulatory Affairs, or Safety Management within the medical device or in-vitro diagnostic industry (optional).
Experience as a General Manager, Quality Assurance Manager, or Safety Management Officer is desirable (optional).
Experience in team management and personnel development (optional).
Basic to advanced knowledge of the Pharmaceutical and Medical Device Act (PMD Act), ISO 13485, QMS Ordinance, and Good Vigilance Practice (GVP) (optional).
High communication skills in Japanese.
Business-level English proficiency (optional).
Experience collaborating in a global matrix organization (optional).

Skills

Quality Assurance
Regulatory Affairs
Safety Management
Compliance
ISO 13485
QMS Ordinance
GVP
PMD Act
Communication
Risk-based decision-making
Continuous improvement
Team collaboration

Location

Tokyo, Japan

Work Type

Onsite
Full-time

Experience Level

5+ years (optional)

Education Level

Bachelor's or Master's degree in Pharmacy, Chemistry, or related science field
Japanese Pharmacist License

Salary/Compensations

¥4,200,000 - ¥7,700,000 per year (includes semi-annual fixed bonuses)
Performance bonus: 10% of base salary (paid based on company and individual performance)

Benefits

Fixed annual salary
Performance bonus
Fixed term employment: None
Working hours: 9:00 - 17:30 (12:00-13:00 break)
Overtime: Available
Management position: Available
Salary basis: Monthly
Probationary period: Yes (typically 3 months, conditions same as post-probation)
Holidays: Saturdays, Sundays, Public holidays, Year-end holidays (12/29-1/4)
Leave: Special leave (condolence, summer vacation, etc.)
Annual paid leave: Up to 20 days per year (accumulated leave system available)
Salary increase: Once a year
Bonuses: Summer bonus, Winter bonus, Performance bonus (paid based on performance)
Training programs: New employee training, product training, sales skills training, hierarchical training, career development support system, etc.
Welfare programs: Group life insurance, long-term disability income compensation insurance, Benefit Premium, health check-up subsidy, condolence/sympathy money, club activities, etc.
Social insurance: Health insurance, Employees' Pension Insurance, Employment Insurance, Workers' Accident Compensation Insurance
Retirement benefit system: 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 helping customers solve their most complex challenges.
We partner with customers across the globe to architect solutions that bring the power of science to life.