RA/ RA

A renowned healthcare company is looking for a RA professional. The selected candidate will ensure compliance with Japanese regulatory requirements, manage product registration, and support business development initiatives. This is a hybrid setup role.

Responsibilities:

• Conduct regulatory assessments and manage submissions, approvals, and registrations
• Maintain compliance with Japanese health authority regulations and oversee license renewals
• Develop and implement regulatory strategies for QMS applications and foreign site registrations
• Review and approve marketing communication materials for regulatory compliance
• Coordinate with global and regional RA teams to align submission planning and regulatory strategies
• Represent the company in external regulatory networks to stay updated on best practices and industry trends

Requirements:

• Bachelor’s degree or above in life sciences
• 6-8 years of experience in regulatory affairs
• Experience with operating room products is a plus
• Knowledge of Japanese regulatory laws and recent amendments
• Strong communication, planning, and negotiation skills
• Business level English

About the Company:

A global leader in medical solutions, this company specialises in advanced wound care and surgical products, helping healthcare professionals improve patient outcomes. With a strong commitment to innovation and sustainability, it delivers high-quality, evidence-based solutions trusted by medical institutions worldwide.

Keywords:

規制当局, 登録申請, QMS適用, 医療機器, 製品承認, 規制戦略, 外国施設登録

Job ref: JWWN5Y