A leading medical device company in the field of robotic surgery is looking for a motivated and detail-oriented Regulatory Specialist to join our team. This is an exciting opportunity to be part of a dynamic startup environment as we transition from development to commercial operations.

Key Responsibilities

– Prepare and maintain regulatory documentation, including Technical Documentation and Design Dossiers for products marketed in the EU.
– Prepare regulatory submissions, particularly in compliance with EU Medical Device Regulation (MDR).
– Assess the impact of product or process changes on regulatory strategy and documentation.
– Ensure compliance with EU MDR 2017/745 and support inspections and audits.
– Review clinical evaluation reports, risk management reports, and FMEAs.
– Monitor regulatory changes and update internal teams accordingly.
– Provide training and support on regulatory requirements and best practices.
– Manage product registrations and regulatory communications.

What We're Looking For

– Bachelor’s degree in Life Sciences, Engineering, or a related field; an advanced degree is a plus.
– 3-5 years of experience in regulatory affairs within the medical device industry.
– Proven experience with CE marking.
– Strong knowledge of EU MDR and relevant regulatory requirements.
– Excellent attention to detail and ability to work independently.
– Strong written English and verbal communication skills.

Location: Yokneam