Director Regulatory and Quality Systems - Minneapolis

Only for registered members Minneapolis, United States

1 week ago

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Full time $132,900 - $199,290 (USD)

Job summary

The Director of Regulatory & Quality Systems is responsible for leading the company's regulatory strategy and ensuring the effectiveness of the Quality Management System (QMS) in alignment with FDA, ISO, and other applicable regulatory requirements.

Responsibilities

  • Develop and execute regulatory strategies to support new product introductions, modifications, and ongoing compliance for Class II medical devices.
  • Lead preparation, submission, and maintenance of regulatory filings including 510(k)s...

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