Regulatory Affairs Senior Specialist

About the role

The Regulatory Affairs Senior Specialist will support the RA Manager and act as a key partner to Quality Assurance, Vigilance and the commercial team for CooperVision Japan. The role focuses on securing regulatory approvals for Class III contact lens devices and translating global strategies into practical plans for the Japanese market.

Key responsibilities

• Lead and coordinate non‑clinical study strategies with global RA and R&D to reduce cost and time to approval.
• Prepare and submit product registration dossiers, license renewals and change notifications to MHLW and PMDA.
• Serve as primary liaison with Japanese health authorities, handling pre‑submission consultations and post‑submission inquiries.
• Assess global standards versus local requirements and evaluate study data for regulatory submissions.
• Share non‑clinical knowledge with regional and global RA teams and participate in industry working groups.

Required profile

• Senior‑level experience in regulatory affairs for medical devices, preferably Class III ophthalmic products.
• Strong understanding of Japanese medical device regulations (MHLW, PMDA).
• Proven ability to coordinate internal and external study teams and manage complex submission timelines.
• Proactive business partner with excellent communication skills.

Required skills

• Regulatory submission preparation
• Non‑clinical study design and coordination
• Knowledge of Japanese medical device regulations (MHLW, PMDA)
• Product registration and license management

What we offer

• Opportunity to work on innovative contact lens products in a leading global company.
• Collaboration with cross‑functional teams across APAC and worldwide.
• Professional development and talent growth support.