Senior Regulation and Quality Project Manager
Manage complex, multidisciplinary medical-device and medical-software projects from planning through regulatory approvals, coordinating clients, regulators, professional teams, and international stakeholders.
Responsibilities
- Lead regulatory processes, quality activities, documentation, and international registrations
- Guide clients through the project lifecycle, from planning to regulatory approval
- Coordinate clients, regulatory bodies, professional teams, and international stakeholders
- Meet professional, operational, and financial targets
- Deliver client value and lead process improvement and optimization
Requirements
- At least 10 years of experience in the field
- Experience as a Quality and/or Regulation Manager at an innovative medical-device manufacturer
- Experience managing complex, multidisciplinary projects
- Valid driver's license
- Strong service orientation and communication skills; able to coordinate multiple stakeholders
Nice to have
- Engineering degree
- ISO 13485 Auditor certification