QA and Design Control Manager with proven experience in the medical devices industry to join our team and contribute to the effective maintenance of our (MDR) ISO13485 certified Quality Management system and move us ahead with the implementation of QMS that is compliant with FDA 21 CFR Part 820 regulation.
Job Responsibilities:
Responsible for managing or governing all QMS related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Management Reviews, Changes, Complaints handling, Recalls, data analysis, Risk management.
Provide professional QA and Regulatory guidance throughout the entire product lifecycle: from the early feasibility through planning, and development until the post-marketing stages.
Assuring production line compliance and working closely with the QA at the contracted manufacturer.
Reports directly to the VP of Regulatory Affairs QA

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