RA Manager - Abbott Molecular
Core
Lead regulatory affairs strategy for in vitro diagnostic (IVD) and related medical devices in Japan, managing the product lifecycle from development to market access and post-market compliance.
Role type
Senior Regulatory Affairs Manager (IVD/Molecular Diagnostics)
Builds
Regulatory and market access strategies for new and existing IVD products in Japan
Domain
Healthcare / Molecular Diagnostics / Regulatory Affairs
Required skills
Regulatory strategy, Project management, Stakeholder negotiation, Team leadership, Risk management, Compliance knowledge
Preferred skills
Companion Diagnostics experience, Insurance reimbursement strategy, Global team management, Quality Assurance background
Technologies
None stated
Responsibilities
Develop and execute regulatory strategies for new product launches and existing product expansion; Lead negotiations with PMDA and Ministry of Health, Labour and Welfare; Manage regulatory submissions and approvals; Oversee lifecycle management including variation approvals and post-market surveillance; Lead QMS compliance investigations; Manage and develop the regulatory team; Collaborate with cross-functional teams on market access plans.
Seniority
Senior, hands-on IC with people management