A Medical device company in Rehovot (near a train station) is seeking a Medical Device RA Manager.
Primary purpose and function of this position:
Provide Regulatory Guidance for device and drug/device combination elements throughout the full product life cycle.
Review device life-cycle documentation
Support compliance assurance to local authorities and regulations.
Lead device labeling activities
Lead post-marketing changes
Lead Regulatory projects and provide specific strategies to post-market changes
Regulatory point of contact for some device vendors
Lead device-specific submission chapters
Requirements: BS in engineering or equivalent.
8+ years RA experience in supporting a medical device development and manufacturing environment.
Knowledge, Skills Abilities:
Post market experience
Working knowledge of QSRs, ISO 13485, MDD/MDR, MDSAP, and FDA requirements and standards.
SW RA knowledge - advantage
Strong interpersonal, communication, analytical and complex problem solving skills.
Ability to take ad-hoc decisions and communicate properly to management
The ability to develop partnerships and influence.
Ability to work independently.
An understanding of the principles of configuration management and document control.
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