Quality & Regulatory Assistant Manager
Core
Own product quality and regulatory compliance for ophthalmic lens products across APAC, covering new product introduction, customer complaints, and product registrations.
Role type
Senior Quality & Regulatory Assistant Manager (Medical Devices/Optical)
Builds
Ophthalmic lens products (Varilux, Crizal, Stellest) for global distribution
Domain
Medical Devices / Optical Industry / Regulatory Affairs
Required skills
ISO 13485 QMS management, root cause analysis, CAPA, regulatory compliance (FDA, MOH, CE), risk assessment, change control, technical documentation review, supplier evaluation
Preferred skills
Experience in ophthalmic lenses or optical products, APAC market knowledge, travel readiness
Technologies
MS Office
Responsibilities
Manage new product introduction through order release; Obtain and validate test reports from factories; Manage customer complaints end-to-end including root cause investigation and CAPA; Monitor regulatory changes across APAC markets; Support customers' product registrations; Prepare Quality Agreements and compliance documents; Assess and mitigate risks for product and manufacturing changes; Act as Quality Management Representative for ISO 13485 QMS
Seniority
Senior, hands-on IC