עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
מלאה
14,000-18,000 ₪
our company, a Sisram Medical company, is a global leader in medical-aesthetic technologies, with over 25 years of experience in energy-based devices (EBD). Over the years, our company has evolved into an integrated aesthetic and wellness ecosystem that combines medical devices, injectables, diagnostics, and personalized skincare. The company operates in a dynamic, innovation-driven environment, merging advanced technology with deep clinical understanding to create holistic solutions for aesthetic clinics. our companys headquarters are in Caesarea, Israel, with business operations in more than 100 countries worldwide. Key Responsibilities A. Risk Management - Mandatory / Top Priority
* Perform and maintain risk management activities according to ISO 14971 across the full product lifecycle.
* Develop, update, and maintain Risk Management Files (RMF), including:
* Perform FMEA (all types)
* Hazard identification
* Risk analysis and risk evaluation
* Risk control measures and mitigation strategies
* Residual risk assessment
* Benefit-risk analysis
* Lead and actively participate in risk analysis activities and meetings (e.g. FMEA, FTA, Hazard Analysis).
* Ensure technical risks specific to energy-based systems are properly identified, documented, and controlled, including (HW, SW, Clinical etc.):
* Verify, document, and maintain evidence of risk control effectiveness.
* Integrate design data, design/engineering changes, service feedback, complaints, and postmarket information into ongoing risk evaluations.
* Provide risk-related input for:
* New design project
* Design changes and product modifications
* CAPAs
* Product improvements
* Regulatory submissions and updates
* AE - Adverse Events
* PMS activities B. Regulatory, PMS & Adverse Event Responsibilities (Core Responsibility)
* Perform postmarket surveillance (PMS) activities in accordance with global regulatory requirements, including data collection, analysis, and documentation.
* Conduct adverse event (AE) and complaint assessments, including:
* Initial assessment and classification
* Support and execution of investigations
* Risk evaluation and impact assessment on product safety and performance
* Reporting to regulatory authorities
* Ensure integration of AE, complaint, service, and PMS data into risk management files, maintaining continuous risk evaluation.
* Perform trend analysis of complaints, adverse events, and postmarket data to identify safety signals, emerging risks, or systemic issues.
* Prepare and maintain PMS documentation, including contribution to and preparation of PSURs, with clear linkage to risk management outputs.
* Participate in and support regulatory assessments and submissions.
* Perform and maintain risk management activities according to ISO 14971 across the full product lifecycle.
* Develop, update, and maintain Risk Management Files (RMF), including:
* Perform FMEA (all types)
* Hazard identification
* Risk analysis and risk evaluation
* Risk control measures and mitigation strategies
* Residual risk assessment
* Benefit-risk analysis
* Lead and actively participate in risk analysis activities and meetings (e.g. FMEA, FTA, Hazard Analysis).
* Ensure technical risks specific to energy-based systems are properly identified, documented, and controlled, including (HW, SW, Clinical etc.):
* Verify, document, and maintain evidence of risk control effectiveness.
* Integrate design data, design/engineering changes, service feedback, complaints, and postmarket information into ongoing risk evaluations.
* Provide risk-related input for:
* New design project
* Design changes and product modifications
* CAPAs
* Product improvements
* Regulatory submissions and updates
* AE - Adverse Events
* PMS activities B. Regulatory, PMS & Adverse Event Responsibilities (Core Responsibility)
* Perform postmarket surveillance (PMS) activities in accordance with global regulatory requirements, including data collection, analysis, and documentation.
* Conduct adverse event (AE) and complaint assessments, including:
* Initial assessment and classification
* Support and execution of investigations
* Risk evaluation and impact assessment on product safety and performance
* Reporting to regulatory authorities
* Ensure integration of AE, complaint, service, and PMS data into risk management files, maintaining continuous risk evaluation.
* Perform trend analysis of complaints, adverse events, and postmarket data to identify safety signals, emerging risks, or systemic issues.
* Prepare and maintain PMS documentation, including contribution to and preparation of PSURs, with clear linkage to risk management outputs.
* Participate in and support regulatory assessments and submissions.
Requirements:
* Minimum 3-5 years of experience in medical device risk management.
* Proven experience working with ISO 14971 risk management processes.
* Experience with Class II / IIb medical devices - strong advantage.
* Experience with energy-based or laser medical devices - highly preferred.
* Experience in a regulated medical device environment (RA/ QAgreenTxtBg!).
* Experience with PMS/ adverse events / vigilance / complaints - strong advantage.
* Bachelors degree in Engineering, Life Sciences, Biomedical Engineering, or a related field.
* Strong knowledge of medical device risk management principles (ISO 14971).
* Solid technical understanding and ability to analyze engineering and clinical risks.
* Regulatory awareness of FDA QSR, EU MDR and global regulatory expectations.
* Experience with risk analysis tools (FMEA, Hazard Analysis, RCA).
* Ability to integrate post-market data into risk evaluations.
* High attention to detail and strong documentation skills.
* Minimum 3-5 years of experience in medical device risk management.
* Proven experience working with ISO 14971 risk management processes.
* Experience with Class II / IIb medical devices - strong advantage.
* Experience with energy-based or laser medical devices - highly preferred.
* Experience in a regulated medical device environment (RA/ QAgreenTxtBg!).
* Experience with PMS/ adverse events / vigilance / complaints - strong advantage.
* Bachelors degree in Engineering, Life Sciences, Biomedical Engineering, or a related field.
* Strong knowledge of medical device risk management principles (ISO 14971).
* Solid technical understanding and ability to analyze engineering and clinical risks.
* Regulatory awareness of FDA QSR, EU MDR and global regulatory expectations.
* Experience with risk analysis tools (FMEA, Hazard Analysis, RCA).
* Ability to integrate post-market data into risk evaluations.
* High attention to detail and strong documentation skills.
This position is open to all candidates.
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
קיסריה
ירושלים
ערב
10 חודשים
תעודה ממשלתית
סבסוד
