Director of Quality Assurance and Regulatory Compliance

3 days ago


Cleveland, Ohio, United States Centerline Biomedical Full time

Job Summary

The Director of Quality Assurance and Regulatory Compliance will lead the development, implementation, and management of quality assurance and regulatory compliance programs at Centerline Biomedical. This role is crucial for ensuring that our products meet all necessary regulatory standards and that our quality management system (QMS) supports our commitment to excellence.

Key Responsibilities

  • Quality Management: Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.
  • Regulatory Affairs: Develop regulatory strategies for new product development and market entry, ensuring compliance with FDA, CE, and other international regulatory requirements.
  • Leadership and Collaboration: Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization.
  • Training and Education: Develop and conduct training programs on quality and regulatory requirements for employees.

Requirements

  • Bachelor's degree and at least 15 years' quality and regulatory experience working with medical devices (preferably class II and class III); advanced degree preferred.
  • Strong leadership and communication skills.
  • Experience with new product development and approval with original product submissions (CE Mark and FDA 510(k)).
  • Experience with maintaining medical device quality systems and complaints, specifically ISO 13485.
  • Lean, Six Sigma, ASQ or similar certification beneficial.
  • Proven track record of successful regulatory submissions and maintenance of regulatory compliance.


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