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Purpose Statement/General Statement:
Responsible for pre & post market regulatory activities for Mazor’s products (regulatory assessments and submissions, reportable events, field actions)
Key Responsibilities & Authorities:
• Regulatory assessments & submissions.
Support design and development of products from a regulatory perspective. Perform regulatory assessments for new / revised products.
Review promotional material and labeling for regulatory compliance.
Write, update and maintain technical files.
Prepare regulatory submissions / document rationales (letters to file) for modifications when appropriate (worldwide).
• Reportable events, Field Actions & recalls.
Assessment of potentially reportable events worldwide, when necessary - report reportable events (worldwide).
Field Actions & Recalls assessment, execution and follow up (worldwide).
Keep track of global recalls and MDRs of different companies and identify the ones which require assessment.
Lawyer or B.S. Degree, in a related scientific or engineering discipline.
Minimum Experience: 4 years of applicable experience working in medical device companies.
Extensive understanding and knowledge of medical device regulations and standards, especially US (FDA) and EU (MDD/MDR) related
Job Specific Skills (Languages, SW, systems, etc.'):
Excellent verbal and written communication skills (Hebrew and English).
Office proficient, experience and understanding of ERP, PLM, LMS, Doc Control systems.