Leitung Quality Assurance/ Regulatory Affairs (m/w/d)
Core
Lead Quality Assurance and Regulatory Affairs for a minimally invasive circulatory support system for patients with acute heart failure.
Role type
Senior Quality Assurance and Regulatory Affairs Lead
Builds
Class III medical device products
Domain
Medical technology / Cardiovascular devices
Required skills
Regulatory compliance (ISO 13485, MDR, MDSAP), Medical device product approvals, Quality Management System (QMB) oversight, PRRC responsibilities, Internal and external audit management, Stakeholder communication, R&D and production collaboration
Preferred skills
Leadership, Negotiation
Technologies
ISO 13485, MDR, MDSAP
Responsibilities
Implement regulatory requirements, Obtain product approvals for Class III medical devices, Manage regulatory responsibilities (QMB/PRRC), Lead internal and external audits, Communicate with authorities and notified bodies, Collaborate with R&D and production teams
Seniority
Senior, hands-on IC