The Regulatory Affairs Post-Market Specialist leads and executes key post-market activities to ensure compliance with the Israeli Ministry of Health (AMAR) and requirements. This includes managing adverse event (vigilance) reporting, coordinating Field Safety Corrective Actions (FSCAs), and serving as a regulatory contact for post-market issues in Israel. The role involves close collaboration with cross-functional and global teams to maintain the highest standards of quality and patient safety.
Responsibilities may include the following and other duties may be assigned:
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
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Requirements: Bachelors 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
This position is open to all candidates.