Senior Regulatory Affairs Specialist
Core
Lead global regulatory submissions, develop strategies for new product development and market entry, and advise cross-functional teams on compliance for robotic-assisted surgery systems.
Role type
Senior Regulatory Affairs Specialist
Builds
Regulatory strategies and technical documentation for product registrations and variations
Domain
Healthcare / Robotic Surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory requirements expertise, Project leadership, Technical documentation review, Agency negotiation, Strategic planning, Audit management
Preferred skills
Training and mentoring, Metrics tracking
Technologies
None stated
Responsibilities
Lead global regulatory submissions for product registrations and variations, Develop regulatory strategies for new product development and market entry, Advise cross-functional teams on global compliance requirements, Oversee preparation of technical files and documentation for audits, Manage agency communications for complex product approvals, Mentor and coach regulatory affairs specialists
Seniority
Senior, hands-on IC