Senior Regulatory Affairs Specialist
Core
Executes post-market surveillance activities including complaint handling, product field actions, recalls, and commercial holds for medical devices in the GSA region.
Role type
Senior Regulatory Affairs Specialist (Post-Market Surveillance)
Builds
Post-market surveillance processes and compliance documentation for medical devices
Domain
Medical Devices / Regulatory Affairs
Required skills
Post-market surveillance, complaint handling, vigilance, product field actions, recalls, commercial holds, stakeholder coordination, regulatory documentation, process improvement
Preferred skills
Cross-functional matrix organization experience, project management, quality systems (TrackWise), German language fluency
Technologies
TrackWise, Microsoft Office
Responsibilities
Execute post-market surveillance activities (complaints, PFAs, recalls, holds), coordinate local execution of field actions and holds, review product scope and inventory, act as operational interface between RAQA and stakeholders, support communication with Competent Authorities, maintain tracking systems for product events, monitor post-market environment and regulations, develop and improve PMS procedures and SOPs, prepare for regulatory inspections and audits, monitor PMS metrics and KPIs, identify process improvement opportunities
Seniority
Senior, hands-on IC