Medical Device Regulatory Specialist

This is a one-year contract position where you will play a key role in ensuring that our Pre-market regulatory activities align with both local regulations and internal standards. You'll manage submissions, compliance tasks, and regulatory communications with a proactive, timely, and quality-focused approach.

• Manage Pre-market activities, including submissions of new products, renewal and changes to the local regulatory authorities.
• 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 regulatory laws and guidelines.
• Support change submission processes, including preparation and tracking of the relevant medical device changes.
• Perform Regulatory Operations activities, including coordination with our Global Trade Services (GTS) to release blocked orders and control product distribution in accordance with Distribution Control Compliance requirements.
• 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.

To be successful in this role, you will need:

• A Bachelor's degree in a 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.
• Working knowledge of global regulatory frameworks including MDR.
• 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.

We offer a competitive Salary and flexible Benefits Package. A commitment to your well-being is at the core of our values. We recognize your contributions and share in the success you help create. Our benefits package includes:

• A competitive salary.
• A flexible benefits package.
• Ongoing training and development opportunities.
• A supportive and collaborative work environment.