(MedTech) BURA Staff, Regulatory Affairs

Key Responsibilities:
• Execute action related regulatory compliance by having preventive and avoidance action doing risk analysis and management in RA part.
• Take action to inquiry and/or instruction from Health Authority as a representative from Business Unit Regulatory Affairs in JJKK
• Make RA strategy (incl. incl. clinical study/clinical evaluation strategy) for new product introduction by collaborating internally and having discussion and negotiation with Health Authority
Will report to Business Unit Regulatory Affairs manager or head. The Business Unit will be determined considering candidate's experience and preference.
Qualifications
Education:
• Bachelor's degree or an equivalent qualification is required, and an advanced degree is preferred.
Experience and Skills:
Required:
• Experienced Class II/III/IV Medical Device regulatory submission at least 3 years (especially negotiation experience with PMDA/MHLW related to regulatory submission/approval)
• Fluent communication both in Japanese and English (ex, TOEIC >730)
• Strong scientific background (e.g. Medical engineering, Regulatory science, Biology, Chemical, Mechanical Engineering, Electrical Engineering)
Preferred:
• Basic RA/QA/VS knowledge and rich experiences (at least 5 years) in communication of regulatory requirements and regulatory issues.
• Experience of Class III/IV Medical Device regulatory submission leveraging Clinical Study Report/Clinical Evaluation Report (CSR/CER) is highly regarded.
Skills & Competencies:
• Project management
• Stakeholder management
• Self-development
• Adaptability