Quality Assurance and Regulatory Affairs Professional

1 week ago


Markham, Ontario, Canada Fluidigm Full time
About Us

We are a leading provider of indispensable life sciences tools that is accelerating global research on multiple frontiers of human health.

Estimated Salary: $80,000 - $110,000 per yearJob Description:

The Quality Assurance/Regulatory Affairs Associate will play a key role in ensuring the company's quality system meets requirements for medical devices and international directives. This position is responsible for maintaining technical documentation files, overseeing the company REACH and Safety Data Sheet program, and approving quality records.

  • Maintain Technical Documentation files in compliance with international requirements.
  • Oversee the company REACH and Safety Data Sheet program.
  • Approval and release of Quality Records, Device History Records, Batch Records Master Labels and Device Master Records.
Required Skills and Qualifications:
  • Bachelor's degree required, life science / engineering.
  • Regulatory Affairs / Quality Management RAC certificate is preferred.
  • Knowledge with REACH, RoHS, WEEE, CE mark, UKCA directives and Safety Data Sheet compliance.
About Our Company Culture

At our company, we value innovation, collaboration, and continuous improvement. We strive to foster an inclusive work environment where our employees can excel and grow in their careers.



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