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מעל 80,000 משרות • 4,000 חדשות ביום
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המימד השלישי

מספר מקומות

המימד השלישי

מספר מקומות
מלאה

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.

This position is open to all candidates.