Director of Quality Assurance and Compliance

2 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €120,000
Strategic Director for Quality and Regulatory Affairs

This role requires a seasoned professional with expertise in Quality Assurance and Regulatory Affairs to lead the organization's quality management system.

The ideal candidate will have a proven track record of ensuring regulatory compliance and developing strategic plans to drive business growth.

Key Responsibilities:

  • Develop and implement a comprehensive QA/RA strategy that aligns with business goals and regulatory requirements.
  • Oversee regulatory submissions and communications with global regulatory bodies.
  • Ensure compliance with FDA, EU MDR, and other applicable regulations.
  • Lead the implementation and maintenance of ISO 13485 certified Quality Management System.
  • Manage internal and external audits, CAPAs, and risk management activities.
  • Collaborate cross-functionally with R&D, Clinical, and Operations teams to ensure regulatory and quality requirements are met throughout the product lifecycle.
  • Monitor changes in global regulations and standards, and proactively update internal processes.
  • Mentor and develop the QA/RA team, fostering a culture of compliance and continuous improvement.

Qualifications:

  • Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
  • Proven years of working experience in QA/RA within the medical device industry.
  • Proven experience with FDA submissions (510(k), PMA) and EU MDR compliance.
  • Strong knowledge of IEC 62304, IEC 60601, and ISO 14971.
  • Experience leading audits and managing QMS under ISO 13485.
  • Excellent leadership, communication, and project management skills.
  • Ability to work in a fast-paced, innovative environment.

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