QA&RA Expert

Job Description:
For a start-up developing products for the medical/big data field, with offices in the Sharon area
Additional Positions:
QA
Category:
Biotechnolgy, Science and R&D
Job Qualifications:
B.A or B.Sc. degree in a relevant field
1-3 years Quality Assurance/Regulatory experience as QA/RA expert in the medical device company.
Knowledge in ISO13485, FDA QSR, and EU MDR requirements
Experience with software medical device (IEC62304, SDLC)- is preferred.
Demonstrated knowledge of regulatory issues, and experience interfacing with local & international regulatory bodies, such as FDA, European
competent authorities & notified bodies, Health Canada, etc.
Experience of routine QA activities: CAPA, MRB, ECO, Complaints etc..
Demonstrated management skills; ability to prioritize, plan, evaluate & execute deliverables for established tactical goals.
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level
products & related processes.
Proactive leader with strong ownership and excellent interpersonal relationships
English Proficiency.

Company Occupation:
High Tech