Regulatory Compliance Engineer

4 days ago


South San Francisco, California, United States Spirair, Inc. Full time
Join Our Team as a Regulatory Compliance Engineer

Spirair, Inc. is a leader in the medical device industry, committed to delivering high-quality products that meet or exceed regulatory standards. As a Quality Engineer at Spirair, you will be responsible for supporting our Quality Management System, ensuring compliance with FDA regulations and industry standards.

About the Position

This is an exciting opportunity to join a forward-thinking company and make a meaningful contribution to the development of innovative medical devices. Your primary responsibilities will include:

  • Developing and implementing quality plans, participating in risk management, and conducting supplier audits.
  • Leveraging your expertise in FDA regulations and industry standards to drive compliance across the organization.
  • Collaborating with cross-functional teams to identify and address quality issues, ensuring timely resolution and corrective action.
Requirements

To excel in this role, you will need:

  • 5+ years of experience in quality engineering for medical device manufacturers.
  • A deep understanding of FDA regulations and industry standards, including QSRs and ISO 13485.
  • Exceptional communication and problem-solving skills, with the ability to work effectively in a fast-paced environment.
Compensation

Spirair offers a competitive salary range of $145,000 - $180,000, comprehensive benefits, and opportunities for growth and professional development.



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