Medical Device QA/RA Project Manager JB-5297
- Center District, Israel
Mentioned in this posting
- Regulatory Compliance
- ISO Standards
Description
We are seeking a Senior Project Manager – Regulatory and Quality in Medical Devices and AI. The role includes: • Managing complex, multidisciplinary projects in the field of medical devices and medical software. • Leading regulatory processes, quality assurance, documentation and international registration. • Accompanying customers throughout the entire project lifecycle, from the planning stage to obtaining regulatory approvals. • Managing interfaces with customers, regulatory bodies, professional teams and international stakeholders. • Responsibility for meeting professional, operational and financial objectives. • Creating value for the customer and leading improvement and efficiency processes. Requirements: • At least 10 years of experience in the field – required • Experience of at least one position as a Quality and/or Regulatory Manager in an innovative medical device manufacturing company – required • Experience in managing complex, multidisciplinary projects – required • Passion for the worlds of medical devices, regulation and innovation – required • High service orientation, excellent communication skills and ability to work with many interfaces – required • Engineering degree – advantage • ISO 13485 certified auditor – advantage • Valid driver's license – required