Director of Regulatory Affairs

Job Title: Director of Regulatory Affairs
Department: QA/RA
Position Scope: Full-Time
Location: Caesarea

About XACT Robotics

XACT Robotics is a rapidly growing medical robotics startup company. Our technology is designed to be compatible with a broad range of imaging modalities, capable of delivering various instruments to a desired target for a wide range of clinical applications and indications.

Working at XACT Robotics allows you to exercise your creativity. We encourage our employees to develop themselves, grow their careers and execute meaningful technologies that make an impact on the lives of patients.

If you have passion, drive, and a winning spirit, don`t miss this opportunity.

Main Responsibilities

  • Responsible for directing the company on international market medical device regulatory requirements (with strong emphasis on USA, European and Asian regulatory systems), and takes a central role in shaping the company regulation policy and strategy.
  • Conduct research and analysis on regulatory requirements and policies for new projects.
  • Take central role in shaping the company regulation policy and strategy.
  • Act as the technical expert for all regulations (MDSAP, FDA, CE(MDR), ISO, etc.) ensuring the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
  • Monitor external regulatory developments and changes and communicate these changes issues to senior management.
  • Review and approve all regulatory documents submitted to regulatory authorities.
  • Ensure all internal and external changes are conducted according to regulatory requirements and provide regulatory guidance to the different teams across the company.
  • Work side by side with the R&D, Product, Operation, Quality teams, and management, maintaining and ensuring that the company meets FDA, CE, ISO 13485, and additional quality and regulatory requirements.
  • Manage relationships within the relevant regulatory agencies to improve the quality of submissions and understand the impact of any pending or proposed regulatory changes.
  • Act as the point of contact on all regulatory information related to company’s work for external parties.
  • Review and approve all regulatory aspects related to company’s distributors.
  • Working with all regulatory consultants.
  • Responsible for maintaining the cyber security requirements (HIPPA, GDPR, ISO 27001).
  • Act as regulatory project leader for all projects that involves regulatory aspects for new products and developments.
  • Act as Person Responsible for Regulatory Compliance.

Qualifications & Requirements

  • A degree in law, medicine, pharmacy, engineering or another relevant scientific discipline.
  • Scientific or legal MSc – a plus.
  • Concise and effective verbal and written communication skills – ability to challenge, influence, and articulate a view and drive behavior or action and train employees.
  • Highly motivated, self-learner.
  • Demonstrates high level of professionality and accuracy, knows how to get the job done
  • Target and objectives oriented with a “can-do” attitude.
  • At least three years of professional experience in regulatory affairs in the medical devices industry with proven experience of regulatory submissions to FDA, and CE.
  • Experience with MDSAP, FDA QSR part 820, ISO 27001, ISO 14975 and ISO 13485 standards.
  • Fluent in English.
  • Max. file size: 50 MB.

Contact Us

XACT ACE™ Robotic System is the world’s first and only hands-free robotic system that combines advanced image-based procedure planning and navigation with robotic instrument insertion and non-linear steering capabilities.