Director of Quality and Regulatory Affairs

1 month ago


Cleveland, Ohio, United States Centerline Biomedical Full time
Job Summary

The Director of Quality and Regulatory Affairs 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

  • Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.
  • Oversee internal and external audits to ensure compliance with regulatory requirements and internal policies.
  • Set and achieve QMS Key Performance Indicators (KPIs) to drive ready compliance quality culture.
  • Lead continuous improvement initiatives to enhance product quality and operational efficiency.
  • Ensure timely resolution of quality issues and non-conformances.

Regulatory Affairs

  • Develop regulatory strategies for new product development and market entry, ensuring compliance with FDA, CE, and other international regulatory requirements.
  • Prepare and submit regulatory filings, including 510(k), PMA, and international submissions, as required.
  • Monitor and interpret regulatory developments and communicate implications to the executive team.
  • Maintain regulatory documentation and ensure all records are accurate and up-to-date.

Leadership and Collaboration

  • Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization.
  • Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure quality and regulatory considerations are integrated into all phases of product development and commercialization.
  • Serve as the primary point of contact with regulatory bodies and notified bodies, managing all communications and inspections.

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.
  • Strength in data analysis, trending, and forecasting of metrics.


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