Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist
Department: Regulatory Affairs / Quality Assurance
Reports To: VP RA/QA
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.

Objective

The Regulatory Affairs Specialist will work with product development, Engineering, and the commercial team to ensure that product development processes and changes to existing products meet applicable regulatory requirements. Furthermore, other company processes are in compliance with requirements set by various regulatory authorities.

Main Responsibilities

  • Works in the QA-RA department on assigned projects.
  • Coordinates with ‘Product’ and/or ‘Research and Development’ teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies.
  • Collaborates with key staff from Planning, Product Development, Operations, and Engineering departments as required (ECOs, pre-launch activities, labeling requirements, etc.)
  • Notifies Regulatory Affairs Manager when compliance issues arise or are identified, when regulatory reports are delayed, and when other immediate action is required.
  • Serves as a representative for the regulatory affairs department at process review meetings.
  • Establishes and maintains business relationships with officials in federal and state government regulatory agencies.
  • Responsible for maintaining Up-to-date Reg. Affairs documentation (Tech Files, correspondence with regulatory authorities, certificates, etc.)
  • Performs other related duties as assigned.

Qualifications & Requirements

  • Bachelor’s degree in related field required.
  • 2 years of related experience preferred.
  • Preparing and maintaining Reg. Affairs documentation
  • Extensive knowledge of applicable federal and state regulations and the ability to stay current on regulations.
  • Knowledge and understanding of EU MDR regulations for medical devices.
  • Familiarity with relevant standards (ISO, EN, IEC, etc.)
  • Excellent written and verbal communication skills.
  • Cooperative team-player who can efficiently collaborate with other staff members
  • Excellent analytical and problem-solving skills.
  • Proficient with Microsoft Office Suite or similar software.

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.