Risk Management & Vigilance Specialist

Description:

Alma, 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, Alma 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. Alma’s 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 post‑market 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 post‑market 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 post‑market 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.
• Ensure all PMS, AE, and risk-related documentation is accurate, traceable, and audit‑ready.
• Participate in internal and external audits related to risk management, vigilance, and PMS activities.

• 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/QA).
• Experience with PMS/ adverse events / vigilance / complaints – strong advantage.
• Bachelor’s 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.
• Excellent analytical, problem-solving, and critical-thinking abilities.
• Ability to work independently and collaboratively in cross-functional teams.
• Strong ability to prioritize tasks, manage tight deadlines, and drive activities to completion in a regulated environment.
• Strong written and verbal communication skills.
• Self-learner
• Fluency in English (written and spoken).