Associate Regulatory Affairs Specialist

About the role

Medtronic is looking for an Associate Regulatory Affairs Specialist in Herzliya to join its Regulatory Affairs team. The role ensures that pre-market regulatory activities in Israel align with local Ministry of Health (AMAR) regulations and internal Medtronic standards, managing submissions, compliance tasks and regulatory communications proactively and with a focus on quality. The specialist works closely with global regulatory teams, operation units and local stakeholders.

Key responsibilities

• Manage pre-market activities, including submissions of new products and renewals and changes to the Israel Ministry of Health (AMAR)
• Provide strategic input from regulatory planning through to execution and follow-up of submissions
• Maintain regulatory and technical documentation of registered products required by the Israel Medical Device Law and MOH guidelines
• Support change submission processes, including preparation and tracking of medical device changes
• Perform regulatory operations, coordinating with Global Trade Services to release blocked orders and control product distribution in line with Distribution Control Compliance requirements, including import/export and quality standards
• Gather and analyse information with global regulatory teams and take part in cross-functional teams to meet timelines and resolve regulatory issues

Required profile

• Bachelor's degree in a scientific discipline
• At least 2 years' experience in regulatory affairs or quality assurance
• Full professional proficiency in Hebrew and English
• Experience in the medical device industry
• Familiarity with local regulatory authorities and submission processes (e.g. AMAR)
• Attention to detail, ability to work independently and under pressure, and strategic thinking

Required skills

• Working knowledge of global regulatory frameworks including the MDR (Medical Device Regulation)
• Knowledge of local regulatory authorities and submission processes

What we offer

• A competitive salary and a flexible benefits package
• Eligibility for the Medtronic Incentive Plan (MIP), a short-term incentive