Regulatory Affairs Specialist

Microbot Medical is a cutting-edge medical device endovascular robotic surgery company, seeking a motivated and enthusiastic Regulatory Specialist to join our team.

We are on a mission to revolutionize endovascular procedures, with the LIBERTY® Endovascular Robotic System. LIBERTY is designed to revolutionize the surgical robotics marketplace as a single-use and fully disposable robotic system for endovascular procedures. LIBERTY overcomes many obstacles that hinder the adoption of other robotic systems by eliminating the large capital expense, and creating a system that is easy to use with a short learning curve.

As we transition from development to commercial operations, we are seeking a dynamic and experienced RA Specialist to join our team.

This position offers an exciting opportunity to work in a dynamic startup environment and engage in a variety of tasks, fostering professional development and personal fulfillment.

Responsibilities:

-  Prepare and maintain regulatory documentation, including Technical Documentation and Design Dossiers for products marketed in the EU.

-  Prepare submissions for regulatory authorities, especially per EU Medical Device Regulation (MDR).

-  Assess the impact of any product changes, process modifications, or updates to existing regulations on regulatory strategy and documentation.

-  Implement regulatory requirements in accordance with EU MDR 2017/745 and assist and support inspections and audits.

-  Review clinical evaluation reports, risk management reports and FMEAs.

-  Ensure compliance with relevant EU directives and regulations.

-  Monitor changes in medical device regulations and standards and update internal teams accordingly.

-  Provide training and support to internal teams on regulatory requirements and best practices.

-  Maintain RA administration: product registrations, preparing responses to regulatory authorities, and maintaining records of regulatory communications.

Qualifications:

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