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Senior Regulatory Affairs Project Manager
Не указаноПолная занятостьRegulatory Affairs ManagementMedical Devices
Lead complex medical device and medical software projects, guiding customers through regulatory and quality processes from planning to approval.
Обязанности
- Lead multidisciplinary medical device and medical software projects
- Manage regulatory processes, quality assurance, documentation, and international registrations
- Guide customers through the project lifecycle, from planning through regulatory approval
- Coordinate customers, regulatory bodies, professional teams, and international stakeholders
- Meet professional, operational, and financial objectives
- Drive customer value, improvement, and efficiency initiatives
Требования
- At least 10 years of relevant experience
- Experience as a Quality and/or Regulatory Manager at an innovative medical device manufacturer
- Experience managing complex, multidisciplinary projects
- Strong service orientation and communication skills; ability to manage multiple stakeholders
- Valid driver's license
Будет плюсом
- Engineering degree
- ISO 13485 certified auditor