Medical Device Director

1 day ago

Galway, Galway, Ireland beBeeRegulatory Full time

Are you a results-driven professional with experience in Quality Assurance and Regulatory Affairs?

Hobson Prior is seeking an exceptional Director of QA/RA to lead their quality assurance and regulatory affairs functions. This role is critical in ensuring medical devices meet global regulatory requirements and quality standards, with a strong focus on FDA, EU MDR, and compliance with IEC 62304 and IEC 60601 standards.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

  • Develop and implement a comprehensive QA/RA strategy, ensuring alignment with business goals and regulatory requirements.
  • Oversee regulatory submissions and communications with global regulatory bodies including the FDA, EMA, and Notified Bodies.
  • Ensure compliance with EU MDR, FDA 21 CFR Part 820, and other applicable regulations.
  • Lead the implementation and maintenance of ISO 13485 certified Quality Management System.
  • Ensure product development processes comply with IEC software lifecycle) and IEC electrical safety).
  • Manage internal and external audits, CAPAs, and risk management activities.
  • Collaborate cross-functionally with R&D, Clinical, and Operations 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.

This is an exciting opportunity to join a dynamic organization and contribute to the success of the QA/RA team.

For more information, please contact us.

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