Regulatory Affairs Post-Market Specialist

• Lead the execution and follow-up of Field Safety Corrective Actions (FSCAs) including coordination with internal teams, customers, and submission to the Ministry of Health (MOH)
• Manage the adverse event (vigilance) reporting process to the Israeli MOH, ensuring timely and accurate submissions in accordance with local regulatory timelines and guidelines
• Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities
• Serve as a regulatory contact for the Israeli MOH on all post-market issues, including adverse events, recalls, field actions, and periodic updates
• Stay up to date with changes in AMAR regulations, MOH guidelines, and industry standards, and communicate potential impacts to management and relevant teams
• Participate in the local recall committee or crisis response team in the event of product safety issues requiring urgent action
• Provide training to local teams on vigilance reporting, complaint handling, and FSCA procedures to ensure consistent and compliant practices

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related technical field; advanced degree or relevant certification in Regulatory Affairs is a plus
• Minimum of 3 years of experience in Regulatory Affairs, preferably in post-market surveillance or related compliance activities. Experience in the medical device industry is an advantage
• Excellent project management and communication skills, with a demonstrated ability to collaborate cross-functionally and engage with global regulatory teams
• Detail-oriented and organized, capable of managing multiple priorities while meeting strict regulatory deadlines
• Fluency in Hebrew and English, both written and verbal, is essential
• Experience in post-market activities related to Medical Devices including adverse event reporting, Field Safety Corrective Actions (FSCAs), complaint handling and recall processes is an advantage

Medtronic