Regulatory Affairs Specialist

About the role

Aidoc, a healthcare AI company with more than 2,000 deployments worldwide, is looking for a Regulatory Affairs Specialist to join its Regulatory team. You will support regulatory activities throughout the software development life cycle, including regulatory assessments, worldwide registrations, regulatory submissions and regulatory operations, so that products meet international requirements and industry standards.

Key responsibilities

• Lead regulatory assessments of software changes and product enhancements, evaluate their impact on existing approvals and determine global regulatory requirements.
• Own and drive end-to-end regulatory submissions and product registrations in markets such as Canada, Australia and Brazil, prepare submission dossiers, manage interactions with regulators and answer regulatory queries.
• Lead the creation, review and maintenance of product labels, including localization and translation.
• Review promotional and marketing materials with Marketing, Product and Commercial teams to ensure claims are accurate and compliant.
• Write, update and maintain technical files for Class I and Class IIa products.
• Handle regulatory operations tasks such as updating databases, dashboards and trackers.
• Work with software engineers, data scientists and product teams to identify testing requirements and ensure compliance.

Required profile

• Bachelor's degree in Engineering, Life/Exact Sciences, Quality Assurance or Law.
• 1-2 years in regulatory teams within the medical device industry; experience with SaMD is a plus.
• Interest or background in computer science or AI is a plus.

Required skills

• Structured thinking and ability to read and apply regulatory guidance and standards.
• Analytical skills and data-driven decision making.
• Project and program management skills.
• Ability to work independently with minimal supervision.
• Near-native English, with excellent verbal and written communication.

What we offer

• Hybrid work model with offices in Tel Aviv and employee parking.
• Daily breakfast and lunch prepared by a personal chef, plus a meal card.
• Employee-only gym, Pilates, yoga and functional workout classes.
• Collaborative, transparent culture and an attractive compensation package and benefits.