Regulatory, Quality & Compliance Lead (m/w/d)
Core
Lead Regulatory, Quality, and Information Security functions for a growing SaMD company, driving regulatory maturity and translating complex requirements into pragmatic business decisions.
Role type
Senior Regulatory, Quality & Compliance Lead (Team Lead)
Builds
Regulatory compliant SaMD products under MDR, ISO 13485 QM systems, and ISMS aligned with ISO/IEC 27001 and NIS2.
Domain
MedTech / HealthTech / Software as a Medical Device (SaMD)
Deliverable
production ML models
Required skills
Regulatory Affairs (MDR), Quality Management (ISO 13485), Information Security Management (ISO/IEC 27001, NIS2), Team Leadership, Strategic Planning (via careerplan.io/jobs/2692397-regulatory-quality-compliance-lead-mwd-at-ocumeda-gmbh)
Preferred skills
EU AI Act governance, GDPR compliance in healthcare, IEC 62304, ISO 14971, scaling startup experience
Technologies
MDR, ISO 13485, ISO/IEC 27001, NIS2, EU AI Act, GDPR, IEC 62304, ISO 14971, IEC 82304
Responsibilities
Oversee MDR compliance and technical documentation for SaMD products; Manage QM system development and audit readiness; Steer ISMS implementation; Establish AI Act governance for high-risk AI systems; Ensure GDPR compliance for health data; Integrate regulatory standards into a coherent management system.
Seniority
Senior, hands-on IC with leadership responsibilities
