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 95000 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.

Join our Regulatory Affairs team As an Associate Regulatory Affairs Specialist and be part of a purpose-driven community that is dedicated to improving patient care through high-quality accessible and affordable healthcare.

As an Associate Regulatory Affairs Specialist you will play a key role in ensuring that Medtronics Pre-market regulatory activities in Israel align with both local Ministry of Health (AMAR) regulations and internal Medtronic standards. Youll manage submissions compliance tasks and regulatory communications with a proactive timely and quality-focused approach.
You will work closely with global regulatory teams operation units and local stakeholders to bring life-changing technologies to patients in need while maintaining the highest standards of safety and compliance.

Responsibilities may include the following and other duties may be assigned:

• 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 Medtronics 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.

Required Knowledge and Experience:

• Bachelors 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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Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).