RA Senior Manager
Responsibilities:
- Define Regulatory Requirements for defined company products
- Provide related guidance of the Process and Design Controls (Design and Development Planning, Design Input and Output, Design Review, Verification & Validation, Design transfer, Design changes) regarding defined products to the R&D core teams
- Development and timely submission of regulatory applications, license renewals, periodic updates and registrations of defined products with different regulatory agencies
- Ensure regulatory compliance of defined products and processes
- Disseminate regulatory information to different company departments (Operations, production, Quality assurance, R&D, Marketing, etc.) and senior management, as required
- Develop department procedures and conduct applicable global training regarding same
- Participate in research of arising regulatory issues
Skills and Experience:
- Minimum of 8 years experience with managing regulatory projects and leading registrations of Medical Devices in EU/US/China/Canada markets (in all markets – working with Class II and/or III devices)
- BSC. or B.A. degree in scientific or technical discipline. Advanced degree preferred
- Independent professional
- Leadership skills
- English – Native level language skills (verbal & writing)
- Excellent communication skills (verbally and in writing, both Hebrew and English)
- Ability to multitask and manage multiple projects to meet deadlines
- Ability to work with cross-functional global teams and across different cultures
- Ability to write, review and compile complex documents/submission dossiers (English)
- Management experience of a small team – preferred
- RAPS RAC – advantage
#LI-NDI
A Better Tomorrow
Starts Here
Discover the transformative power of Incisionless Focused Ultrasound.
Start a Transformation©2024 Insightec. All rights reserved.
The information on this website is not intended to be a substitute for professional medical advice. Always discuss treatment options and treatment outcomes with your physician or other qualified health provider.