規制スペシャリスト／エキスパート/ Regulatory Specialist/Expert

A global life sciences consulting company is looking for a Regulatory Specialist/Expert. The selected candidate will oversee end-to-end medical device registration and support regulatory strategy and project delivery in Japan.

Responsibilities:

• Develop and implement regulatory strategies for medical device and IVD registrations
• Manage end-to-end registration process in coordination with internal and external stakeholders
• Lead Japan regulatory submissions and act as subject matter expert
• Translate and review regulatory documents to ensure compliance and accuracy
• Deliver regulatory intelligence and respond to local regulation changes
• Support business development initiatives and internal team training

Requirements:

• Bachelor’s degree or equivalent in chemistry, pharma, engineering, or bio-engineering
• 6-8 years of professional experience
• 2-3 years of experience in medical device
• Experience in pharmaceutical regulatory is ideal
• Prior experience in global regulatory affairs (regulatory strategy, planning and execution
• Proven experience in Class I and II Medical devices
• Background with IVDs is a plus
• Possess valid International Regulatory Affairs Certification is preferred
• Possess valid authorisation to work in Japan
• Native level written and verbal Japanese and English

About the Company:

A global leader in life sciences consulting, this company delivers regulatory, clinical, and quality solutions to support pharmaceutical, biotechnology, and medical device companies worldwide. Known for its innovative approach and deep domain expertise, it empowers job hunters to be part of impactful projects that advance healthcare and compliance on a global scale.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: SUEXRN