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Compliance Engineer for Medical Devices

1 week ago

Burnaby, British Columbia, Canada Verathon Full time
Job Description

This Compliance Engineer position plays a critical role in ensuring the company's products meet regulatory requirements. Key responsibilities include defining compliance engineering requirements, managing standards databases, and collaborating with stakeholders to resolve compliance findings.

  • Author and maintain product technical documentation files according to European Medical Device Directive (MDD 93/42/EEC) and European Medical Device Regulation (MDR) 2017/745.
  • Provide front room and/or backroom support for external audits (such as FDA, Notified Body, etc.).
  • Support the performance of internal audits to determine compliance with Quality Management System (QMS) standards, policies, and procedures.
Skills and Qualifications

A strong understanding of regulatory requirements, quality systems, and international product safety standards is essential for success in this role. Experience working in a QSR/ISO 13485 Quality Management System and MDSAP audits is highly desirable.