Senior Regulatory Affairs Specialist, APAC
Core
Preparing regulatory submissions and maintaining compliance for new or modified medical devices in domestic and international markets.
Role type
Senior Regulatory Affairs Specialist
Builds
Medical device clearances and approvals (FDA PMA/510(k), CE certifications)
Domain
Medical Devices / Cardiopulmonary & Respiratory
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device regulatory submissions (510(k), PMA), FDA and EU Notified Body interactions, global regulatory strategy, CAPA management, SOP development, risk management, project management, knowledge of US and European regulations
Preferred skills
Regulatory Affairs Certification, understanding of engineering concepts and scientific terminology, familiarity with medical terminology
Technologies
None stated
Responsibilities
Coordinate FDA PMA and 510(k) Premarket Notifications, manage CE files and Essential Requirement checklists, represent regulatory affairs on project/product teams, communicate with US FDA, EU Notified Bodies, and international regulatory authorities, review promotional literature and product labeling changes, participate in regulatory audits/inspections
Seniority
Senior, hands-on IC