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Senior Regulatory Affairs Project Manager
Not specifiedFull-timeRegulatory Affairs ManagementMedical Devices
Lead complex medical device and medical software projects, guiding customers through regulatory and quality processes from planning to approval.
Responsibilities
- 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
Requirements
- 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
Nice to have
- Engineering degree
- ISO 13485 certified auditor