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About the Role
This department is responsible for the stable and appropriate provision of in-vitro diagnostic reagents to the Japanese market, handling regulatory affairs applications based on the Pharmaceutical and Medical Device Act and other related regulations, document management such as package inserts, and quality and safety management after product launch. We collaborate with internal and external stakeholders, including business units, quality assurance, safety management, and manufacturers, to maintain compliance throughout the product lifecycle.
Responsibilities
- Lead the regulatory strategy and application process for in-vitro diagnostic reagents and medical devices (equipped with in-vitro diagnostic reagents) in Japan.
- Support product launches and continuous supply through new approval applications, variations, change notifications, package insert revisions, responses to PMDA inquiries and consultations, and preparation/review of documents submitted to regulatory authorities.
- Coordinate with the quality assurance and safety management departments, and manufacturers regarding post-market quality and safety management (QMS/GVP), performing necessary regulatory judgments and document reviews.
- Support subordinates in overall operations.
- Plan, apply for, and obtain approval/certification for regulatory applications according to marketing priorities in communication with Global RA.
- Manage progress, conduct administrative checks, and negotiate with manufacturers as needed.
- Implement appropriate responses for variations and minor changes when product modifications occur.
- Take appropriate action based on specification changes from manufacturers.
- Create and manage statutory labeling, package inserts, and SDS in compliance with the Pharmaceutical and Medical Device Act, Poisonous and Deleterious Substances Control Act, and other relevant laws.
- Take responsibility for creating Important Notices and Pink Notes inserted into products, coordinating with Marketing (customer communication) and Kashiwa DC (product insertion, product standards).
- Review promotional materials for compliance with relevant laws and regulations, and determine the applicability of poisonous and deleterious substances for new imports based on the Pharmaceutical and Medical Device Act, Poisonous and Deleterious Substances Control Act, etc.
- Respond to inquiries from inside and outside the company.
- Submit new applications and change notifications for various business licenses, and manage business licenses appropriately.
- Improve processes related to applications and labeling revisions for efficient operations.
- Coach and guide team members to improve group performance.
- Actively engage in the development of group members.
Requirements
- Minimum of 5 years of experience in regulatory affairs within the medical device (including in-vitro diagnostic reagents), in-vitro diagnostic reagent, or pharmaceutical industry.
- Experience with regulatory applications such as approval applications, variations, minor change notifications, and package insert revisions (including electronic application experience).
- Experience in responding to inquiries, consultations, or preparing/reviewing submission documents with regulatory authorities like PMDA.
- Ability to read English documents and communicate via email and meetings with international stakeholders.
- Project management skills to independently lead multiple projects, coordinate with stakeholders, and achieve deadlines.
Skills
- Regulatory Affairs
- Project Management
- Communication
- Regulatory Submissions
- Quality Management
- Safety Management
- QMS
- GVP
- Regulatory Compliance
- Coaching
- Mentoring
Location
- Headquarters
Work Type
- Full-time
- Remote
- Hybrid
Experience Level
- 5+ years
Education Level
- Pharmacist License (Preferred)
Salary/Compensations
- To be discussed
Benefits
- Employment Insurance
- Workers' Accident Compensation Insurance
- Welfare Pension
- Health Insurance
- Benefit One
- Condolence Money
- Pre-paid Pension/Defined Contribution Pension Plan
- Comprehensive Group Term Life Insurance
- Employee Stock Ownership Plan
- Welfare Subsidy
- Breast Cancer Screening Subsidy
- In-house Club Activities
- Affiliated Daycare Center (within HQ building)
About the Company
- Siemens Healthineers is committed to valuing different ways of thinking and identities. We are dedicated to providing equal opportunities and creating a workplace that reflects the diversity of society. Bring your whole self to work and create a better tomorrow with us. Learn more about our DI&B initiatives here.
Equal Opportunity
- Siemens Healthineers is committed to valuing different ways of thinking and identities. We are dedicated to providing equal opportunities and creating a workplace that reflects the diversity of society. Bring your whole self to work and create a better tomorrow with us. Learn more about our DI&B initiatives here.