Regulatory Affairs Specialist - Fuze Services
Core
Support global regulatory requirements for In-Vitro Diagnostics and Medical Devices across Europe, USA, and Canada, ensuring compliance with marketing authorization, vigilance, and product lifecycle management.
Role type
Regulatory Affairs Specialist (Medical Device/IVD)
Builds
Regulatory submissions, technical files, and compliance documentation for IVD Class A and Class IIa medical devices.
Domain
Healthcare / Medical Devices / In-Vitro Diagnostics
Required skills
EU/US regulatory knowledge, technical file maintenance, SOP creation, audit support, adverse event reporting, change control management, stakeholder communication
Preferred skills
Life sciences degree, experience with EU IVDR/MDR, familiarity with MS Office, project management
Technologies
MS Office
Responsibilities
Create and review SOPs and change control forms; support internal and external audits (ISO 13485:2016); provide regulatory input for new product development including label claims and IFUs; prepare regulatory documents for EU competent authorities and US FDA; maintain EU IVDR and MDR technical files; review product claims in marketing materials; participate in continuous improvement initiatives; prepare status reports and metrics.
Seniority
Mid-level, hands-on IC