Regulatory Affairs Specialist

About the Role

Sion Medical Ltd. is looking for a Regulatory Affairs Specialist to join our team in Sderot.

This role is responsible for regulatory compliance for the company’s products marketed in Israel, including medical devices, cosmetics, pharmaceuticals, and food supplements. The position also supports regulatory activities for the EU, FDA, and other international markets.

• Manage product registrations, renewals, amendments, and notifications with the relevant Israeli authorities.
• Serve as the main regulatory contact with the Israeli Ministry of Health and other applicable local authorities.
• Manage the regulatory Change Control process, including impact assessments, required notifications or approvals, and implementation follow-up.
• Prepare and submit regulatory documentation and respond to authority questions and requests.
• Assess regulatory requirements for new products and product changes.
• Review product labeling, packaging, IFUs, Hebrew translations, and regulatory claims.
• Maintain regulatory licenses, registrations, approvals, and supporting documentation.
• Support EU MDR, FDA, and ROW regulatory activities, including registrations, submissions, authority responses, and compliance assessments.
• Support the creation, maintenance, and updating of Technical Documentation and Technical Files.
• Prepare regulatory documentation for new product development and changes to existing products.
• Monitor changes in Israeli and international regulations and communicate relevant requirements internally.
• Provide regulatory support for product launches, tenders, customer requests, and commercial activities.
• Support the regulatory assessment of complaints, recalls, field actions, and other post-market issues.
• Work closely with QA, Global RA, R&D, Marketing, Sales, Operations, Supply Chain, and external partners.

• Degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, Biomedical Engineering, or a related field.
• Previous experience in Regulatory Affairs.
• Experience with Israeli Ministry of Health regulatory processes is preferred.
• Knowledge of EU, FDA, and other international regulatory requirements is an advantage.
• Experience preparing and maintaining Technical Documentation or Technical Files is preferred.
• Fluent Hebrew and strong professional English.
• Strong organizational, communication, and documentation skills.

Reports to the VP Regulatory Affairs.