Regulatory Affairs Specialist – Japan

About the role

CooperVision Japan (CVJ) is seeking a Regulatory Affairs Specialist to lead and support regulatory activities for contact lens products classified as Class III medical devices. The role works closely with the RA Manager, Quality Assurance, and Vigilance teams to ensure timely approvals and compliance with Japanese health authorities.

Key responsibilities

• Develop and execute regulatory strategies for corporate projects and obtain Japanese regulatory approvals.
• Design and coordinate non‑clinical studies to demonstrate safety and efficacy, collaborating with global RA/R&D and local laboratories.
• Prepare and submit product registration dossiers, license renewals, and change notifications for own‑brand, OEM, and private‑label lenses.
• Interact directly with MHLW and PMDA, supporting pre‑submission consultations and post‑submission inquiries.
• Share non‑clinical knowledge with global and regional RA teams to enhance organizational expertise.

Required profile

• Strong understanding of Japanese medical device regulations and international standards.
• Experience in non‑clinical study planning, execution, and data evaluation.
• Ability to work collaboratively across global and local functions.
• Proactive attitude toward personal talent development.

Required skills

• Regulatory submission preparation
• Non‑clinical study design and coordination
• Product licensing and label compliance