Associate Regulatory Affairs Specialist

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

• →Manage Pre-market activities, including submissions of new products, renewal and changes to the Israel Ministry of Health (Amar), in a timely and organized manner.
• →Provide strategic input from regulatory planning through to execution and follow-up of submissions.
• →Maintain Regulatory and technical documentation of the registered products required by the Israel Medical Device Law and MOH guidelines.
• →Support change submission processes, including preparation and tracking of the relevant medical device changes. 
• →Perform Regulatory Operations activities, including coordination with Medtronic’s Global Trade Services (GTS) to release blocked orders and control product distribution in accordance with Distribution Control Compliance requirements. This includes ensuring compliance with legal regulations related to import/export, regulatory approvals, and quality standards.
• →Collaborate with global regulatory affairs teams and operation units to gather and analyze required information
• →Participate actively in cross-functional teams to meet timelines, resolve regulatory issues, and improve work processes.

• Bachelor’s degree in scientific discipline 
• Minimum of 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)
• Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation) 
• Excellent attention to details, proactive approach and ability to work independently
• High learning agility and ability to work under pressure
• Strategic thinking and ownership of regulatory and quality initiatives

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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