Старший специалист по регистрации (Подразделение медицинских устройств) / Sr RA Specialist
Core
Senior Regulatory Affairs Specialist preparing and supporting registration dossiers for medical devices and IVD products, interacting with state regulatory bodies to maintain product registration status.
Role type
Senior Regulatory Affairs Specialist (Medical Devices/IVD)
Builds
Regulatory dossiers and reports for medical devices and IVD products
Domain
Medical Devices / In Vitro Diagnostics (IVD)
Required skills
Regulatory Affairs experience (5-7 years), Medical device/IVD knowledge, English (fluent), Biomedical engineering/Pharmacy/Medicine degree
Preferred skills
None stated
Technologies
None stated
Responsibilities
Prepare and support registration dossiers for medical devices and IVD products; Interact with state regulatory bodies regarding registration; Develop and implement regulatory strategy for new and existing products; Ensure timely receipt of registration certificates; Evaluate regulatory risks; Consult cross-functional teams on regulatory requirements; Monitor legislative changes and assess impact on product portfolio
Seniority
Senior, hands-on IC