Senior Regulatory Affairs Specialist
Core
Develop regulatory strategies, secure global product approvals, and ensure compliance throughout the product lifecycle for medical technologies.
Role type
Senior Regulatory Affairs Specialist
Builds
Global product registrations, clearances, and approvals for medical devices
Domain
Medical device / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory requirements knowledge, medical product development processes, design controls, regulatory submission management, regulatory agency liaison, analytical problem solving, technical writing, project management
Preferred skills
RAPS Certification
Responsibilities
Develop and execute regulatory strategies for global product registrations; Provide regulatory guidance to product development and manufacturing teams; Prepare and manage regulatory submissions to global health authorities; Assess product and manufacturing changes for regulatory impact; Build and maintain relationships with regulatory agencies; Support internal and external audits; Develop regulatory procedures and mentor colleagues
Seniority
Senior, hands-on IC