Specialist, Regulatory Affairs
Core
Manage EU regional product registrations and ensure compliance with regulatory requirements for medical devices.
Role type
Specialist, Regulatory Affairs (Medical Devices)
Builds
EU market approvals and regulatory submissions for medical monitoring technologies
Domain
Life sciences / Medical technology / Regulatory compliance
Required skills
EU regulatory requirements knowledge, CE-marking expertise, ISO 13485 familiarity, EN ISO 14971 understanding, document control system proficiency, global regulatory experience (FDA, UKCA)
Preferred skills
International corporation experience, cross-cultural leadership collaboration, advanced documentation and traceability skills
Technologies
SharePoint, Salesforce, Oracle Agile PLM, EUDAMED
Responsibilities
Prepare and submit national regulatory applications in the EU region; Process and maintain EU registrations, notifications, renewals, and changes; Manage distributor letters and authorizations; Maintain regulatory records and databases; Support customer service, marketing, and sales with global market approvals
Seniority
Mid-level Specialist